This is a temporary assignment for 6+ months.
Responsibilities include but are not limited to:
- Review of analytical records generated during the testing of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs). Records include, but are not limited to:
- Lot release test records.
- Stability test records.
- Raw material test records.
- Review of records related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to, records associated with:
- Preparation, qualification, and control of standards and controls.
- Test sample chain of custody.
- Preparation, qualification, and control of laboratory reagents.
- Provision of QA support for the stability program, including:
- Review and compilation of stability time point packages and reports.
- Review of stability information submitted in Regulatory filings.
- Interaction with Quality Control group to resolve review observations.
- Maintenance of systems for organizing, tracking, and reporting completed reviews and metrics related to the review system.
- Provide review and input for generation of new or revised QA SOPs and other controlled documentation. Author quality documents as assigned.
- Other duties as assigned.
- Bachelor's degree in a scientific discipline.
- Minimum 2 years work experience in Quality Assurance and/or Quality Control in a GMP regulated environment.
- Familiarity with biotechnological testing methodologies, including HPLC, Immunoassays (e.g. ELISA, Western Blot and SRID), SDS-PAGE, PCR.
- Familiarity with stability program requirements for biotech products.
- Proficiency with Microsoft Office and Outlook.
- Proficiency with Microsoft Access a plus.
- Excellent multi-tasking and organizational skills.
Job Type: Full-time
Salary: $25.00 to $30.00 /hour
- Biotechnological Testing Methodologies: 2 years (Preferred)
- Review Test Records: 3 years (Required)
- Quality Assurance: 2 years (Preferred)
- Microsoft Office: 3 years (Preferred)