The QA Associate – Biologics is accountable to the QA Manager, Biologics and plays a key role in supporting Eurofins CDMO Alphora Inc.’s compliance with Current Good Manufacturing Practices (cGMP) to ensure the production of safe and efficacious clinical and commercial pharmaceuticals on behalf of our clients and their patients.
The QA Associate – Biologics supports quality oversight of GMP activities within the Biologics operating unit, including the development and commercialization of biotechnology-derived pharmaceuticals such as monoclonal antibodies (mAbs), mammalian-based therapeutic proteins, and antibody-drug conjugate (ADC) candidates. Biologics GMP operations include a clinical GMP cleanroom suite, GMP analytical/QC laboratory, and large-scale GMP manufacturing facility with sterile fill-finish capabilities.
DUTIES AND RESPONSIBILITIES:
Support the QA Manager, Biologics in providing quality oversight for GMP activities across the Biologics operating unit, including facilities, bulk processing operations, fill-finish operations, and analytical activities.
- Quality Oversight
- Provide production support including equipment and line clearances.
- Perform oversight of batch manufacturing and final product packaging operations
- Support the review/assess change controls.
- Perform logbook issuance, reconciliation and routine GDP inspections
- Support the development and implementation of the Environmental Monitoring Program and Contamination Control Strategy
- Participate/lead quality oversight initiatives as assigned.
- Batch Review and Release
- Review executed batch records and production cleaning study reports for accuracy, completeness and compliance to established cGMP or other regulatory standards.
- Support assignment of batch disposition to Product’s manufactured/tested at Alphora – ensure all testing and manufacturing records have been reviewed for compliance to GMP and SOPs prior to assignment of disposition.
- Compile batch release documentation packages and related certification statements.
- Testing Data Review and Release
- Review/approve analytical data and protocols for standard qualification, stability, method qualification and method validation protocols for accuracy, completeness and compliance.
- Review/approve quality control lab data for raw materials, in-process controls, intermediates and final products for accuracy, completeness and compliance to cGMP or other applicable regulatory standards.
- Assign disposition to purchased incoming materials
- Deviations and Investigations
- Support the development of investigation plans, conducting investigations, root cause analysis, risk and impact assessments, determination of CAPA, and final report issuance.
- Provide support, guidance and training to other departments.
- Collaborate with clients as required.
- QMS Support
- Participate in the development and continuous improvement of quality systems, policies and procedures based on quality system data/KPIs and Regulations.
- Contribute to writing and review of over Standard Operating Procedures (SOPs).
- Audit Support
- Assist in preparation/coordination of customer and regulatory agency audits.
- Support and/or direct internal company audits.
- Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities.
- Participate in opportunities to develop knowledge of cGMP and business operations.
- Represent Alphora QA on client projects, as assigned.