Quality Assurance Specialist Job Description

Quality Assurance Specialist Job Description

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Quality assurance specialist provides feedback to Engineering, Manufacturing Engineering and Procurement with regard to product and process design impact on produce ability and inspect ability.

Quality Assurance Specialist Duties & Responsibilities

To write an effective quality assurance specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance specialist job description templates that you can modify and use.

Sample responsibilities for this position include:

Works closely with other team leaders, architects from other disciplines in order to effectively test projects/issues
Develop strong documentation that proves the quality of an issue(s) under review
Build a deep understanding of the products that will require scrutiny for quality assurance
Work closely with the BA team in order to accurately define if requirements are feasible based upon current product structure
Reviewing batch Records for API
Drug substance and drug products to verify calculations
Product accountability
Accuracy and proper GMP documentation practices
Preparing them for final review and product release
Batch documentation review and approval prior to product release

Quality Assurance Specialist Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Assurance Specialist

List any licenses or certifications required by the position: ASQ, QMS, ISO, SQF, AS9100, A&P, FAA, HACCP, CWI, II

Education for Quality Assurance Specialist

Typically a job would require a certain level of education.

Employers hiring for the quality assurance specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Education, Engineering, Science, Chemistry, Computer Science, Management, Technical, Biology, Business, Mathematics

Skills for Quality Assurance Specialist

Desired skills for quality assurance specialist include:

Tools
Excel
Microsoft Office
FDA
Ability to apply appropriate processes
Ability to impact decisions within and outside own organization
Ability to leverage that information in creating customized customer solutions
Business process improvement tools and techniques and ability to understand
Effective influencing tactics and strategies
Enhance existing business

Desired experience for quality assurance specialist includes:

Oversee internal manufacturing
Support Commercial QA Compliance, Deviation Review and Trending, CAPA Review and Trending, and Extension request review and trending
Review and approve batch production records and associated supporting documentation
Perform routine manufacturing area inspections to ensure compliance with company procedures/policies, cGMP principles, and regulatory requirements
Provide general off-the-floor QA consultation to manufacturing and support departments
Support miscellaneous QA tasks

Quality Assurance Specialist Examples

1

Quality Assurance Specialist Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality assurance specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality assurance specialist
  • Facilitate and attend calibration sessions
  • Performs other Quality auditing functions and/or other duties as assigned by the Manager
  • Batch Record Review & material release to ensure compliance with GMP
  • Monitor clients' condition and performance of duties by Home Care Aides
  • Maintain all company and Illinois Department on Aging rules, regulations and standards
  • Conduct home visits to new clients to welcome and review the Welcome Packet
  • Observe and evaluate Home Care Aides in the client's home as directed by Supervisor, to assure client Care Plans are being followed
  • Prepare and complete accurate home visit and home safety evaluation reports and case notes as needed
  • Maintain schedule to assure timely completion of all assigned home visits
  • Attend weekly branch meetings
Qualifications for quality assurance specialist
  • Associate degree in computer science or programming, electronics or A/V technology related field (or equivalent experience)
  • Meticulous attention to detail and accuracy is a must
  • Strong familiarity with Windows, UNIX, and Mac environments
  • Third level Scientific degree
  • Five years previous QA/Validation experience
  • Knowledgeable in various analytical wet chemistry test and instruments
2

Quality Assurance Specialist Job Description

Job Description Example
Our growing company is looking to fill the role of quality assurance specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality assurance specialist
  • Act as system administrator of quality coaching tools
  • Monitor QA compliance on program and project quality control activities and related activities
  • Perform internal audits on contract operations to ensure compliance with contract deliverables
  • Conduct internal QA audits on project procedures and Project QCP activities
  • Identify and follow up on nonconformities, potential nonconformities, and opportunities for improvement
  • Support external quality related audits
  • Facilitate and/or coordinate training on compliance with quality control activities to project staff
  • Requires moderate direction to complete more complex tasks
  • Analyze process problem situations by reviewing facts and creating solutions
  • Complete tasks as assigned with minimal supervision and guidance
Qualifications for quality assurance specialist
  • Living the values at Shire is a basic expectation for all Shire employees
  • Minimum of 3 years experience working in the field of senior services, or a closely related social service
  • CNA certificate and license preferred
  • Must demonstrate strong interpersonal and communication skills
  • Experience devising improvements to current procedures and developing models of possible future configurations
  • Experience performing workflow analysis and recommending quality improvements
3

Quality Assurance Specialist Job Description

Job Description Example
Our company is hiring for a quality assurance specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality assurance specialist
  • Developing uniform and standard instructions, procedures and monitoring their proper implementation
  • The research and writing of the policies, procedures and other related documents in compliance with established content standards
  • The compilation of reports and maintenance statistics and compilation of weekly/ monthly reports for overall monitoring
  • Formulating sampling procedures and designs, and developing forms and instructions for recording, evaluating, and reporting quality and reliability data
  • The utilisation of statistical data techniques to monitor performance
  • Developing and implementation of tracking and quality control systems, analysing, quality control, maintenance and other operational reports to detect and resolve problems
  • Studying operations/process sequences, work flows, functional statements, organisational charts and project information to determine worker functions and responsibilities as they relate to quality
  • Planning, promoting, and organising training activities
  • Ensuring continuous improvement in all work-in processes (WIP), finished products and equipment
  • Taking the necessary steps to control potentially unsafe or poor quality functions
Qualifications for quality assurance specialist
  • Ability to work a flexible schedule, including evenings and weekends as necessary holidays
  • 2+ years of Manufacturing and strong Quality Assurance experience
  • Must maintain an expert level understanding of satellite system technology and processes
  • Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 5-8 years of experience in Quality Assurance in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
  • Identifying, writing evaluating and closing Deviations and CAPA
  • Working knowledge of word processor and spreadsheet programs
4

Quality Assurance Specialist Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality assurance specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality assurance specialist
  • Lead and or support management review activities in the BU’s
  • Review and perform quality check on all sales calls according to QA scorecard
  • For sales calls which do not meet QA standard, carry out necessary remedial action
  • Review non sales calls & provide feedback to AVP - Business & Campaign
  • Record the sales calls and maintain a proper record of the calls
  • Conducts test calls to new telemarketers or existing telemarketers on new products
  • Completes all tasks necessary to obtain the information needed to evaluate / monitor work distribution, work quality, process flows, process controls, vendor services, compliance requirements, facility responsibility areas, and operational documentation
  • Completes daily selection of data for review
  • Completes established quality assurance review worksheets
  • Provides detailed documentation to support findings that do not meet acceptable standards
Qualifications for quality assurance specialist
  • Expertise in specialized areas relevant to QA activities, computer systems, root cause analysis, TQM, QC troubleshooting, CAP/CLIA guidelines, and a history of implementing Analytical Measuring Range and proficiency testing process
  • Of the fingers, hands, and wrists
  • Minimum of Bachelor’s in Business or Business-related discipline
  • 5 or more years of experience supporting an quality organization
  • Develops, analyses, trends, maintains and reports corporate metrics
  • Participate in global quality compliance teams and support implementation of harmonized procedures, as required
5

Quality Assurance Specialist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a quality assurance specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality assurance specialist
  • Determines quality standards by studying, tracking and reporting on all customer contact types supported by the Smart Energy COE
  • Verifies results by measuring skills in use of scripts, product knowledge, sales and service ability, greeting, diction, listening, etiquette, objection handling, efficiency, and courteous close of call
  • Provides feedback to agents
  • Evaluates approaches by rating effectiveness of customer care representatives
  • Directs quality initiatives by requiring adherence to quality assurance policies and procedures
  • Contributes to team effort by accomplishing related results for programs based on Service Level Agreements
  • Establish and implement guidelines related to Quality Assurance practices, and cross and microbial contamination prevention for 3rd party contract manufacturing sites and bulk terminals
  • Plan and conduct Quality Assurance and Contamination Prevention audits at third party contract manufacturing sites and bulk distribution terminals to ensure compliance with guidelines
  • Ensure continuous improvement and drive resolution for QA non-conformances related to manufacturing and analytical testing with the appropriate personnel
  • Oversee the development, implementation and compliance of controlled product assurance plans and other QA related documentation
Qualifications for quality assurance specialist
  • ASCP Medical Laboratory Technologist Certification highly preferred
  • BS Degree in biology, microbiology, virology, biochemistry or other life science
  • Have at least 5 years quality assurance experience in microbiology/diagnostic CLIA certified laboratories, IVD manufacturing, medical device manufacturing, or pharmaceutical industry
  • Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) or equivalent
  • Associate’s Degree in a biological science, chemistry or equivalent and a minimum of 1 year of applicable technical experience
  • At least 4 years of experience in regulated industry is required

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