Quality Assurance Specialist Contract
Quality Assurance Specialist to join our Quality Assurance Operations team. The Quality Assurance specialist will be responsible for support of GMP compliance with a focus on Manufacturing and Clinical Immunology areas. The candidate will provide critical review, organization, and Quality oversight of records generated during GMP manufacturing, release and stability testing of biotechnologically produced vaccines, as well as analytical records and data generated for studies conducted under GCLP and GLP guidelines/regulations. This position will require periodic weekend/evening work and travel.
This position reports directly to the QA Operations Manager.
Responsibilities include but are not limited to:
- Review of analytical records and data generated during the manufacturing and/or testing of vaccines for compliance to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), Good Clinical Laboratory Practices (GCLP) and Standard Operating Procedures (SOPs) and protocols. Records and data include, but are not limited to:
- Lot release records.
- Batch Records.
- Clinical Immunology records.
- Conducts final review and approval of manufacturing-related documentation prior to batch release approval
- Preparation of batch disposition documents for review and approval.
- Serves as a technical resource or subject matter expert on manufacturing and techniques within Quality Assurance
- Review and approval of manufacturing technology transfer, qualification and validation documents internally and oversight activities to CDMOs.
- Provide Quality support and oversight for resolution of deviations and non-conformances related to manufacturing activities.
- Provide Quality review and approval for Process Descriptions, Master and executed batch records.
- Provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned.
- Other duties as assigned.
- BS with 5+ years GxP industry experience
- Excellent understanding of Quality Assurance systems
- Strong communication and organizational skills
- Excellent understanding of GMP, GLP, GCP and GCLP expectations
- Knowledge of global regulatory expectations (including FDA and EMA)
Additionally, we prefer candidates that have:
- The established recognition within QA as a technical expert
- Demonstrated success in leading investigations and problem resolution
- Demonstrated success leading a team and training junior staff
- Demonstrated interest and ability to manage technical, operational, and administrative aspects of the team
- Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
- The ability to represent the team cross-functionally; to apply an understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
- The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context
- The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and beyond
- The ability to produce high-quality work on complex problems with cross-functional involvement; to anticipate and proactively prevent risks and compromises to quality
- The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues.
- The capability to consistently develop networks that are diverse in level and function, identify and initiate new relationships as well as creative alliances to accomplish business objectives, and inspire people with diverse needs to work together for mutual benefit
This temporary position may require periodic weekend/evening work.