QA Specialist / Senior Specialist Job Description
QA Specialist / Senior Specialist Duties & Responsibilities
To write an effective QA specialist / senior specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included QA specialist / senior specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
QA Specialist / Senior Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Specialist / Senior Specialist
List any licenses or certifications required by the position: ASQ, ISTQB, MBTA, ISO, SOP, DFSS, CMQ/OE, GCP, QC, PCQI
Education for QA Specialist / Senior Specialist
Typically a job would require a certain level of education.
Employers hiring for the QA specialist / senior specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Chemistry, Biology, Computer Science, Technical, Education, Pharmacy, Biotechnology, Management
Skills for QA Specialist / Senior Specialist
Desired skills for QA specialist / senior specialist include:
Desired experience for QA specialist / senior specialist includes:
QA Specialist / Senior Specialist Examples
QA Specialist / Senior Specialist Job Description
- Provide QA support to initiate, engage and escalate major and critical compliance issues through the site QMS processes deviations and CAPAs
- Liaise with the Quality Manager/Qualified Person, as necessary, on technical issues including deviations, CAPA
- Reviews, assesses and approves deviations and change controls
- Reviewing and releasing of all records associated with external manufactured product
- Conducting record review of executed batch records from CMO operations
- Performing review of records (e.g CoA, CoC, ) and testing results
- Initiating and/or reviewing non-conformances, CAPA's and Change Management
- Conducting record review of executed batch records for finish drug products to support CMO packaging & labeling record review
- Performing review of bulk drug product executed records, if needed
- May own CAPAs associated within the QA unit
- Experience with a breadth of medical devices (class I, II, III, or spanning range from kits to diagnostics to implantable devices) preferred
- Experience with supplier quality and post-market operational activities
- Experience conducting audits independently as lead auditor
- Experience with mobile device management tools like XenMobile, MobileIron, or similar tools a plus
- Living the values at Shire is a basic expectation for all Shire employees/contractors
- BS in Engineering and or Science and a minimum of 3 years of project management, process excellence, and/or project support experience with increasing responsibility in the areas of Quality Assurance
QA Specialist / Senior Specialist Job Description
- Write SQL against relational databases to validate ETL processes and BI reports
- Supports drug product and finish drug product annual review report sections
- Draft quality procedures as needed to support newer business segment
- Interpret and implement quality standards
- Review and approval of protocols, work instructions and other functional testing documentation
- Evaluate audit findings and drive to implement appropriate corrective actions
- Assist in the completion of vendor audit questionnaires
- Hosting and supporting customer (and regulatory) audits of the site
- Acting as a point of contact for general queries relating to QA from customers and project teams
- Supplier audits – determine, schedule and perform supplier audits
- Able to mitigate unexpected change and be able to communicate impacts possible options to recover
- Experience with automation (wrappers) SHELL or PERL scripting would be an asset
- At least 6 years of experience with HP Performance Center
- At least 2 years of experience with AWS automation
- 6 years of experience with DNS
- 6 years of experience with system resources measurement
QA Specialist / Senior Specialist Job Description
- Actively identify, suggest and participate in continuous improvement activities
- Draft, negotiate and complete quality agreements with customers and suppliers
- Oversees the document control processes which include
- Participates on clinical project teams, influences clinical teams toward a state of inspection readiness at all times
- Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials
- Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures
- Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials
- Participates in problem-solving with project teams at investigator sites
- Communicates observations to clinical investigators and clinical program managers
- Documents audit observations
- 6 years UNIX experience with J2EE web hosted solutions
- 6 years UNIX experience with .NET applications
- 6 years of experience with performance test simulations or at least 6 years of experience in performance analysis or at least 6 years of experience in performance tuning or at least 6 years of experience in performance monitoring in a n-tier environment
- Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience
- Related experience in supporting an operational quality control lab
- Bachelor’s degree in Chemistry, or related discipline (QA/RA), with at least 3 to 5 years relevant experience in pharmaceutical or related industry
QA Specialist / Senior Specialist Job Description
- Provide information/entrees for monthly/quarterly quality reports to management, review for trends and the timeliness of technical operations’ completion of quality processes
- Ensures tracking of audit findings
- Contributes to the development of audit procedures and processes
- Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives
- Keeps abreast of and interprets current worldwide regulatory requirements
- Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners providing quality input
- May support clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements
- Supports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings
- Plans, schedules, and conducts vendor audits
- Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs
- Professional knowledge in GSP, GMP and GDP
- Practical experience in SAP
- Problem solving ability and skill
- Ability to self learning
- Review and approval of executed documents
- Achieves quality assurance objectives by contributing information and analysis to strategic project plans and reviews
QA Specialist / Senior Specialist Job Description
- Assist team with identifying, creating, fleshing-out, and decompose requirements
- Create, modify, and review contractually required technical documentation such as architectural documents, activity diagrams, entity-relationship diagrams, design documents
- Maintain schedules and coordinate activities for project efforts while maintaining high quality execution
- Collect, track and report test metrics and brief leadership on test status
- Identify interdependencies, ambiguities or omissions
- Evaluate the test automation strategy and approach to identify and recommend areas of improvement
- Ensure successful coding and maintenance of automated unit tests
- Debug test-automation failures and test-environment issues
- Identify, troubleshoot and provide solutions for issues
- Effectively manage test data
- Participate to the Quality Compliance Scorecard (QCS) meetings (both locally and globally) as required
- Be a CAPA Manager
- Create all the necessary reports / metrics / KPI’s required by the Site and Global network
- Manage Quality Projects as requested by Management and role
- Job responsibilities will be primarily focused on North Reading (Massachusetts site) site with primary focus on warehouse operations
- Bachelor’s degree in Life Sciences or Equivalent Experience