Laboratory Associate Resume Samples

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DN
D Nader
Dixie
Nader
213 Angel Neck
Boston
MA
+1 (555) 189 7983
213 Angel Neck
Boston
MA
Phone
p +1 (555) 189 7983
Experience Experience
Chicago, IL
Laboratory Associate
Chicago, IL
Bartoletti, Lang and Becker
Chicago, IL
Laboratory Associate
  • Execute laboratory work plan / schedule developed by supervisor or senior team member
  • Provide assistance to Research scientist, Postdoctoral scientists and Lab manager
  • Assign work; ensure proper workflow of the unit; act as lead worker
  • Ensures compliance with established TSOPs and reporting schedules for assigned assay. Ensures the work is done within contracted timeline
  • Execute plan/schedule developed by supervisor
  • Identify process improvements to increase data quality, lower costs or reduce turnaround times. Assist in the implementation of changes as assigned
  • Maintain all laboratory requipment, including ordering supplies; perform repair work, and schedule professionsl repair
Phoenix, AZ
QC Laboratory Associate
Phoenix, AZ
Schimmel, Barton and Reichert
Phoenix, AZ
QC Laboratory Associate
  • Perform sterility testing for the Microbiology Lab. If assigned to that area. Impact: Ensure adherence to USP and FDA guidelines for sterility testing
  • Work Independently
  • Perform bacterial endotoxins test for LAL Lab. If assigned to that area. Impact: Ensure adherence to USP and FDA guidelines
  • Perform GLP and general laboratory functions. Impact: Ensure adherence to departmental policies
  • Perform chemistry testing for the Chemistry Lab. If assigned to that area. Impact: Ensure adherence to ISO and FDA guidelines
  • Serve on Master Compliance Plan Teams (MCP) to assist in resolving non-comformances. Impact: Ensure adherence to FDA and company policies
  • Maintain laboratory equipment cleaning and servicing. Impact: Ensure adherence to QSR, ISO, department and company policies
present
Chicago, IL
Laboratory Accessioning Associate
Chicago, IL
Nicolas, Runte and Lynch
present
Chicago, IL
Laboratory Accessioning Associate
present
  • Assist in general upkeep of laboratory (i.e., lab equipment maintenance)
  • Maintain strict standards of quality and assist with QC and QA activities
  • Flexible schedule to sometimes work on weekends
  • Perform DNA extraction runs
  • May review Standard Operating Procedures (SOPs) and provide input as assigned
  • Interact with Customer Service for any issues related to sample processing within lab
  • Communicate with Client Services to resolve missing information cases
Education Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Strayer University
Bachelor’s Degree in Chemistry
Skills Skills
  • Strong attention to detail and accuracy
  • Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
  • Proficiency with basic laboratory calculations, such as dilutions and weight
  • Proficiency with pipetting and molecular biology laboratory techniques
  • Proficient in at least one core technique
  • Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
  • Mathematical and reasoning ability
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Ability to work effectively under pressure to meet deadlines
  • Good negotiation and reasoning skills
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15 Laboratory Associate resume templates

1

Laboratory Associate Resume Examples & Samples

  • Experience in the nanofabrication laboratory and/or cleanroom environment. Fundamental knowledge of cleanroom structure, airflow and air purification is essential
  • Excellent interpersonal skills for working with a large, diverse university community
  • Time management, organizational skills, and overall ability to work efficiently and independently
  • Excellent oral/written communication skills as well as computer literacy skills to include work processing, spreadsheets, databases and presentation software knowledge
  • Outstanding interpersonal skills are a key for success in this role
  • A Master’s degree is preferred, but not required
2

Laboratory Associate, Analytical Development Resume Examples & Samples

  • Preferred - Knowledge and experience in protein analysis procedures
  • Ability to perform a variety of simple laboratory tasks
  • Ability to perform daily work assignments accurately, timely and in a safe manner with frequent supervision
  • Ability to maintain and complete all laboratory documentation in clear and accurate language and according to SOP
  • Ability to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines
  • Ability to communicate project status to project leader
  • Ability to use Excel, Word, and other office systems
3

Laboratory Associate Buffer Prep Resume Examples & Samples

  • At least 0-2 years in a biotech laboratory setting
  • Preferred - Experience operating, maintaining, and troubleshooting stirred vessel bioreactors and/or protein purification and/or molecular biology cloning and sequencing techniques and/or protein analysis procedures
  • Preferred - Aseptic technique experience
  • Experience following standard operating procedures
  • Ability to manage time effectively to complete assignments in expected time frame
  • Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP
4

Metrology Laboratory Associate Resume Examples & Samples

  • Schedules and Coordinates routine calibrations, PM, and repairs
  • Reviews Calibration Documents
  • Updates Trackwise Investigations
  • Writes, Reviews, and Approves SOPs
  • Updates Visual Boards daily and Maintains Lab Metrology Spreadsheet
  • Manages the new instrument on-boarding process (CapEx, IQ/OQ/PQ, etc.)
  • Calibrate instruments or assist others in troubleshooting
  • Conducts training for vendors and end users
5

Laboratory Accessioning Associate Resume Examples & Samples

  • Accessioning patient samples in a BSL-2 lab
  • Identify any issues that may adversely affect the quality of test results and reporting these to appropriate representatives to ensure prompt resolution
  • Resolve data discrepancies and missing information
  • Perform DNA extraction runs
  • Picking up clinical packages from shipping company in the morning as needed
  • Communicate with Client Services to resolve missing information cases
  • Assist in general upkeep of laboratory (i.e., lab equipment maintenance)
  • May review Standard Operating Procedures (SOPs) and provide input as assigned
  • Interact with Customer Service for any issues related to sample processing within lab
  • Maintain strict standards of quality and assist with QC and QA activities
  • Maintain documentation of all communications in accordance with department procedures and policies
  • Ad-hoc projects as directed by the team leader
  • Participate in continuing education
  • Traditionally a Monday-Friday role, but may require a weekend shift periodically
6

Quality Laboratory Associate Resume Examples & Samples

  • Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility. Work under minimum supervision
  • Serve as a Mentor to Quality Laboratory Associate (QLA) positions. Provide training and work direction for QLA I positions as required
  • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data
  • Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
  • Investigate deviations and write exception documents
  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs
  • Perform equipment maintenance and calibrations as required
  • Other projects as assigned
  • Proficient in wet and instrumental methods of analyses
  • Advanced laboratory skills, basic knowledge of statistical method
  • Strong technical problem solving skills
  • Ability to handle multiple tasks concurrently, and in a timely fashion
  • Must be able to communicate effectively with supervisors and peers
  • Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion
  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience
7

Associate Laboratory Project Services Manager Resume Examples & Samples

  • Strong interpersonal and client management skills
  • Working understanding of medical and clinical research terminology
  • Working knowledge of Project Management processes, Q2 Solutions Laboratory processes, and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) preferred
  • Demonstrated computer proficiency with Microsoft Office and Q2 Solutions systems, or equivalent experience with similar Centralized Laboratory systems preferred
  • Experience in successfully leading Phase I-IV clinical trials preferred
  • Demonstrated ability to work in a fast-paced while possessing strong organizational skills and a demonstrated ability to meet deadlines
  • Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred
  • Bachelor’s degree in Life Sciences and/or related field preferred
  • 1-3 years of experience in clinical trials/ hospital-funded research, project management or laboratory environment preferred
8

Laboratory Associate Resume Examples & Samples

  • Execute plan/schedule developed by supervisor
  • Complete specified activities aligned with individual goals
  • Inform supervisor and interacts with peers in a clear, timely and professional manner
  • Focus is on meeting needs of internal customers only, in the context of outputs to the next stage of workflow, and external customer expectations
  • Write clear, concise technical conclusions in laboratory notebooks
  • Understand extra effort sometimes required to meet group deadlines
  • Focus is on personal learning and skill development. Identifies improvement opportunities in lab operations in which they have demonstrated proficiency
  • Follow established procedures to complete routine testing; may develop solutions for basic technical problems
  • Take personal responsibility to be honest and direct
  • Take ownership to promptly report errors, deviations, OOS or other unusual occurrences in the lab to supervisor
  • Comply with Health, Safety & Environmental responsibilities
  • Participate in local team or cross-functional teams of limited scope
  • Assure compliance and integrity of laboratory work, and meets personal commitments
  • Proactive to address work issues at the individual level
  • Understands personal role in job performance metrics
  • Independent on a daily basis
  • Recognizes unmet needs within local team
  • Strategy is focused on personal and team time management and efficiency
  • Proficient in at least one core technique
  • Executes routine laboratory procedures and methods with minimal errors
  • Mathematical and reasoning ability
  • Ability to work effectively under pressure to meet deadlines
  • Good negotiation and reasoning skills
  • Ability to easily learn and retain technical information
  • Well organized with ability to handle multiple activities simultaneously
9

Laboratory Associate Resume Examples & Samples

  • Execute laboratory work plan / schedule developed by supervisor or senior team member
  • Edits technical documents, such as test methods, with direct guidance from a supervisor or senior level scientist
  • Performs parallel review of laboratory documentation
  • Demonstrates laboratory techniques as part of training
  • Participates in assigned improvement projects
  • Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
  • Ability to learn and retain technical information
  • Executes routine laboratory procedures and methods with high quality
  • Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
  • Mathematical and scientific reasoning ability
  • Proficient in core techniques
  • Ability to operate assigned laboratory equipment
  • Ability to identify aberrant/out of specification data
  • Lead by example according to Catalent's values and culture
  • Strategy is focused on personal time management and efficiency
  • Well organized with ability to multitask
10

Laboratory Associate Resume Examples & Samples

  • Proactively address work issues at both an individual level and a team level
  • Executes procedures or methods of moderate complexity with high quality
  • Basic understanding of instrument operations and troubleshooting skills in multiple techniques
  • Ability to identify aberrant/out of spec data and limited interpretation of data expected
  • Excellent written and verbal communications skills with internal and external customers
  • Demonstrate leadership capabilities in a matrix environment
  • Recognizes unmet needs within department
11

Associate Laboratory Project Set-up Manager Resume Examples & Samples

  • Perform database configuration and programming review and approve verification unit testing while adhering to the database design requirements
  • Responsible for updates to the project tracking database, action/issues logs, status sheets and timelines during the set up phase
  • Lead in the development of sponsor specific standards and program-specific set-up procedures
  • Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate
  • As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.)
  • Coordinate and mentor more junior staff; may assist in training new staff on assigned to projects
  • Report on team performance against contract, customer expectations, and project baselines to management
  • Demonstrated computer proficiency with Microsoft Office and Quintiles LIMS system
  • Demonstrated ability to work in a fast-paced, high stress environment
  • Knowledge of Project Management processes and terminology
  • Good organizational and operational skills
  • Good accuracy and attention to detail skills
  • Strong written and verbal communication skills including good command of English language
  • Bachelor's degree in science related field and minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience
12

Laboratory Associate Resume Examples & Samples

  • Fundamental knowledge of the operating characteristics of electron microscopes, vacuum systems and data storage
  • Operational knowledge of the Transmission Electron Microscope, the Scanning Electron Microscope, the Focused Ion Beam Scanning Electron Microscope and additional sample preparation instrumentation (i.e. ultramicrotome, sputter coater, critical point dryer, glass knife breaker, etc.)
  • Excellent interpersonal skills for working with a large, diverse university community, and strong oral/written communication skills as well as computer literacy skills (to include word processing, spreadsheets, databases and presentation software knowledge)
  • Time management and organizational skills are a preferred to work efficiently and independently
13

Associate Laboratory QC Inspector Resume Examples & Samples

  • Provide Quality Control (QC) documentation support to operations
  • Perform QC review of documentation such as Sample Login binders, run binders, extraction paperwork, Lab notebooks, Data tables, and reports Participate in review of technical and QC SOPs to ensure compliance with appropriate regulations
  • Actively participate in QC educational programs: in-house workshops, presentations on current QC issues, QC training and QC Seminars for all new employees, etc
  • Participate in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance
  • Work in conjunction with operation individuals to improve quality systems
  • Manage and schedule all assigned quality control projects with minor assistance from coworkers and manager
  • May track and report deviation trends to management
  • Evaluate all systems for gaps, recommend actions and professionally communicate to management the analysis to continually improve quality
  • Demonstrate continuous self-motivated quality development
  • Proactively take steps to improve quality systems
  • Laboratory experience in a GLP environment
  • Knowledge of word-processing, spreadsheet, and database applications
  • Knowledge of GLP regulations and guidelines and basic quality review techniques
  • Effective organization, communication
14

Associate Laboratory Project Set-up Manager Resume Examples & Samples

  • Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable in accordance with the requirements of the Clinical Protocol
  • Perform database configuration and programming review and approve verification unit testing
  • Collaborate with colleagues during planning & handover meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
  • Responsible for providing updates to the Project Manager regarding action/issues logs, status sheets and timelines during the start-up phase
  • Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
  • As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings
  • Coordinate and mentor more junior staff; may assist in training new staff
  • Possess strong interpersonal skills
  • Demonstrated computer proficiency with Microsoft Office
  • Working knowledge of Clinical Trials Management Systems would be an advantage [examples QLIMs, NewLIMs, TOPCAT, Encompass]
  • Excellent accuracy and attention to detail skills
  • Strong written and verbal communication skills written & spoken, influencing & negotiating
  • Bachelor's degree or equivalent education and experience; science related background is advantageous but is not essential
  • Minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience
15

Associate Laboratory Specialist Resume Examples & Samples

  • Experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
  • Demonstrated analytical aptitude, critical thinking skills, and problem solving
  • Demonstrated ability to upskill / coach others
  • Experience in pharmaceutical laboratory operations or related environment
16

Associate Laboratory Project Set-up Manager Based Resume Examples & Samples

  • Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable
  • Collaborate with senior colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
  • Communicate and coordinate set-up activities with clients and internal customers to ensure approvals are met, launch is successful, and a seamless transfer of the project to the Project Manager
  • Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally
  • Participate in external and internal audits as required
  • Possess strong interpersonal skills for interaction with senior members within sponsor organizations
  • Possess an understanding of medical and clinical research terminology
  • Previous knowledge of Quintiles Laboratories processes and computer systems is highly desired
17

Laboratory Associate Resume Examples & Samples

  • Provide assistance to Research scientist, Postdoctoral scientists and Lab manager
  • Work closely with students
  • Processing of infectious samples and virus titrations
  • Plan and schedule experiments consistent with the timeline and objectives of ongoing research projects
  • General maintenance of the laboratory. Maintenance of Good Laboratory Practice, comply with Biosafety guidelines, keep inspection records and generate SOPs and reports
  • Maintain and troubleshoot equipment
  • Optimize, develop, qualify and execute the following assays: ELISA, ELISPOT, PCR, Real Time PCR, T cell cloning, virus eradication assays and flow cytometry
  • Participate in group meetings as well as national and international conferences
  • Prepare data for publication
  • Perform any other duties as appropriate within their competence, as required
18

Laboratory Associate Resume Examples & Samples

  • Working closely with students
  • Processing of infectious samples
  • Optimize, develop, qualify and execute the following assays: ELISA, ELISPOT, PCR, Real Time PCR, flow cytometry, virus growth, titration, virus injection, zebrafish embryo and drosophila maintenance
19

Associate Lead-molecular Diagnostics Laboratory Resume Examples & Samples

  • Analytical ability to operate technical equipment, perform tests with the highest degree of accuracy and to relate tests results to a normal, healthy state and to the presence of disease
  • Ability to perform successfully despite sudden deadlines and changing priorities, maintaining personal composure in high stress situations. Ability to exercise initiative and judgment
  • Ability to work independently, determining appropriate procedures and methods to obtain test results
  • Ability to maintain effective communication within the department and with other health-care professionals. Participates in the training of new employees, students and physicians in laboratory methodology
20

Laboratory Associate Supr Resume Examples & Samples

  • Manage and assist research team members (undergraduate/graduate students, post-doctoral fellows, faculty and/or staff)
  • Perform project administrative duties (e.g., assist with IRB regulatory management, maintain paperwork, order equipment and supplies, contribute to the development of project reports, proposal, and presentations, and complete participant payment/incentive pay)
  • Oversee data checking and management process
  • Use a script to provide information about the research study and keep call logs
  • Act as a liaison between site personnel, research team, and PI
  • Assist with
  • Establishing and maintaining partnerships with community partnerships (i.e., preschools and local schools)
  • Participant recruitment
  • Communicating with parents/guardians, teachers, administrators, etc
  • Managing communication between PI and research team
  • And other duties as assigned
21

Laboratory Associate Resume Examples & Samples

  • Ensures compliance with established TSOPs and reporting schedules for assigned assay. Ensures the work is done within contracted timeline
  • Demonstrate leadership through accountability and collaboration in daily activities
  • Consistently demonstrate a high level of initiative and problem solving ability
  • Coordinate efforts to effectively work with others in a way that is productive and promotes cooperation. Recognized as an organized participant or leader of meetings
  • Demonstrate effective two-way communication with co-workers, immediate managers, suppliers, internal and external customers, via meetings, written and verbal interactions, to create an informed positive environment
  • Demonstrate competency in two or more of the following responsibilities
22

Laboratory Associate Resume Examples & Samples

  • Collect and label multiple sample types
  • Perform chemical analysis on specimens
  • Centrifuge and aliquot specimens
  • Take volumes on timed samples
  • Order and record test results in lab computer system
  • Perform, monitor, and document quality control for all testing
  • Perform and document routine instrument maintenance and calibrations; troubleshoot instrument problems
  • Process samples referenced to outside laboratories
  • Bachelor's or Associate's degree and the requisite courses to meet CLIA requirements for moderate to high complexity testing
  • MT, MLS, or MLT (ASCP) certification or equivalent within six (6) months of hire or promotion. Ongoing active certification is strongly preferred
  • External MLT Candidates should have four (4) years of experience in a healthcare setting of moderate to high complexity testing beyond POC/Waived testing
  • Internal MLT Candidates should have two (2) years of experience at NorthShore performing moderate to high complexity testing beyond POC/Waived testing
  • Previous laboratory experience in high complexity testing preferred
  • Demonstrated effective communication and organization skills
  • Demonstrated ability to work cooperatively with others, proven initiative and above average job performance
23

Laboratory Associate Resume Examples & Samples

  • Complete and prepare documentation in compliance with regulatory and corporate guidelines
  • Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines
  • Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that the results are within acceptable tolerances
  • Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to senior lab personnel immediately
  • Perform routine calibration and maintenance of laboratory equipment as assigned
  • Assist in the review and development of laboratory procedures and techniques
  • Identify process improvements to increase data quality, lower costs or reduce turnaround times. Assist in the implementation of changes as assigned
  • Notify inventory staff of supply shortages
  • Participate in continuing education through self-study, attending training sessions and off-site lectures and meetings
  • Working knowledge of Good Clinical Laboratory Practices (GCLP) and other regulatory agency standards within the area of responsibility such as CLIA requirements
  • Proficiency with pipetting and molecular biology laboratory techniques
  • Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
  • Proficiency with basic laboratory calculations, such as dilutions and weight
  • Experience using Microsoft Outlook, Word and Excel
  • Associate's degree with 2 years’ experience in a clinical laboratory operating under GCLP and/or CLIA guidelines or Bachelor's degree in a science discipline; or equivalent combination of education, training and experience
  • Experience with tissue culture
24

Laboratory Associate Resume Examples & Samples

  • Provide support activities for the research and/or teaching needs of designated laboratories and to administer the daily operational policies of the laboratories
  • Supervise, train, assist and/or instruct faculty and students using laboratory facilites
  • Monitor activites within designated laboratories
  • Maintain all laboratory requipment, including ordering supplies; perform repair work, and schedule professionsl repair
  • Assist faculty on project fesability and design
  • Administer safety programs
  • Act as a liason with local industry regarding specifications and availability of new and used laboratory equipment
  • Recommend space and equipment assignments as requested and resolve any conflicts for space and equipment
  • Assign work; ensure proper workflow of the unit; act as lead worker
  • Peform related duties based on departmental need
25

Associate Director, Imaging Core Laboratory Resume Examples & Samples

  • Maintain daily imaging operations
  • Oversee imaging systems
  • Perform quantitative data for submission on imaging techniques; and
  • Identify and implement efficiencies, best practices and standardizing processes
  • *This position is located in our global headquarters in Cincinnati, OH***
  • Bachelor’s degree and 6 years related pharmaceutical industry experience or MBA with 4 years related pharmaceutical industry experience
  • At least 2 years of Imaging Core Laboratory supervisory experience
  • Demonstrated interpersonal skills; and
  • Previous clinical experience
26

QC Laboratory Associate Resume Examples & Samples

  • Perform ALL laboratory testing related to product release in accordance with FDA and ISO guidelines. The tasks cover Microbiology, LAL, Cytotoxicity and the Chemistry Departments for this generic title. Impact: Ensure that product is safe and effective
  • Perform all activities required for the execution of the laboratory test methods in all pertinent areas. Impact: Ensure adherence to the GLP’s regulations
  • Perform sterility testing for the Microbiology Lab. If assigned to that area. Impact: Ensure adherence to USP and FDA guidelines for sterility testing
  • Perform Cytotoxicity testing for the Cytotoxicity Lab. If assigned to that area. Impact: Ensure adherence to USP and ISO guidelines for determining toxicity of raw and finished materials
  • Perform bacterial endotoxins test for LAL Lab. If assigned to that area. Impact: Ensure adherence to USP and FDA guidelines
  • Perform chemistry testing for the Chemistry Lab. If assigned to that area. Impact: Ensure adherence to ISO and FDA guidelines
  • Maintain laboratory equipment cleaning and servicing. Impact: Ensure adherence to QSR, ISO, department and company policies
  • Maintain laboratory inventory of supplies. Impact: Ensure adherence to departmental policies
  • Validate laboratory test method (PQ) to support GLP and QSR requirements. Impact: Ensure compliance to FDA regulations
  • Validate laboratory equipment (IQ/OQ/and PQ) to support GLP and QSR requirements. Impact: Ensure compliance to FDA regulations
  • Perform GLP and general laboratory functions. Impact: Ensure adherence to departmental policies
  • Computer literate or trainable including custom analytical instrument programs. Impact: Ensure adherence to departmental policies
  • Write laboratory methods. Impact: Ensure adherence to departmental policies
  • Adhere to all safety and laboratory rules. Impact: Ensure adherence to OSHA, departmental and company policies
  • Train others in comparable tasks. Impact: Ensure adherence to departmental policies
  • Serve on Master Compliance Plan Teams (MCP) to assist in resolving non-comformances. Impact: Ensure adherence to FDA and company policies
  • Quality Standards
  • Microbiology/Chemistry
  • Theories and Lab Practices
  • Data Compilation Techniques
  • Company/Departmental Policies
  • Problem Resolution Techniques
  • Teaching Techniques
  • Computer
  • Electronic Measuring Devices
  • Calculator
  • Scientific Instrument
  • Oral Presentation
  • People Skill
  • Mechanical Aptitude
  • Meet Deadlines
  • Communicate Effectively
  • Exercise Initiative
  • Work Independently
  • Demonstrate Professionalism
  • Superior Listening Skills
  • Draw Conclusions Based on Facts
  • Interpret Scientific Data
  • Bachelor’s degree from a four year college or university or three to four years related experience and/or equivalent combination of education and experience. Must have general biology or chemistry laboratory experience. 1-3 years
  • 1 year QA/QC/QSR/ISO/FDA Training
  • 1 year Safety Training
  • 1-3 years experience in the biological or chemical sciences
  • 1 year Scientific Industrial experience
  • 1 year QSR/ISO experience
  • 2 years QC experience
  • 3 years Technical Writing experience
  • 3 years Computer experience
  • 2 years Mechanical aptitude