Quality Assurance Specialist
Brief Job Summary:
Reviews Manufacturing and/or Testing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to established procedures/regulatory compliance. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner.
- Compiles and reviews Manufacturing batch records in accordance to cGMP and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
- Compiles and reviews raw data, batch records and test results, including Final Reports in accordance with cGMP, GLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
- Maintains awareness of activities by routine direct observation of in-house laboratories, Cell Production suites and facility. Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support system. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
- Participate as needed to support internal and/or client audits.
- Write and revise SOPs as necessary.
- Verifies and releases shipments of finished product or cell bank vials to clients or contract labs.
- Perform QA inspections including, but not limited to: filled vials, room clearances for in-house laboratories and/or Cell Production, GLP studies.
- Participate in quality and process improvement initiatives, and project teams.
- Perform CAPA effectiveness evaluation.
- Evaluate and perform trend analysis and report results for quality metrics under the guidance of Management.
- Review and Approve document change request with limited authority.
- Assists Management in the training of new hires
- Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, etc.)
- Performs other duties as required.
- Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
- Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).
- Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
- Ability to record data accurately and legibly.
- Ability to use judgment as dictated by the complexity of the situation.
- Ability to understand and follow verbal or demonstrated instructions.
- Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
- Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
Education Required: BA/BS degree in a Science related major
Years of Experience: 3-5
To apply please click on this link: https://home.eease.adp.com/recruit/?id=9170701