Job DescriptionJob #: 1026674
Quality Assurance Specialist opening for an exciting opportunity with one of our growing clients located near the West Chester, PA area.
The QA Specialist will interact with groups to ensure accurate and compliant release of intermediates and final product.
- Review of Manufacturing Batch Record documentation for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product
- Review and disposition of manufactured Bulk Drug Substance and Drug Product Injection lots
- Review of Quality Control testing data against established specifications
- Quarantine and Final Disposition of raw materials to Manufacturing and Quality Control
- Receipt of Quarantine Bulk Drug Substance vials for storage and distribution of Bulk Drug Substance vials for testing and/or manufacture
- Packaging of Biopsy Kits for shipment
- Packaging of final product for shipment
- Assist the Quality Assurance Management in daily operations, as needed
- Conducting Quality on the Floor audits within the Aseptic Processing Area (APA)
- Establish and monitor Quality Assurance programs and procedures to ensure compliance
- Write and revise Quality Systems SOPs as necessary to maintain compliance
- Training of other employees
- Conducting deviations and investigations through the use of problem solving tools
- Minimum Bachelor of Science degree in a scientific discipline
- Minimum two years in a similar role in the biologics or pharmaceutical industry
- Familiarity with Batch Records and controlled documentation
- Experience in aseptic processing and mammalian cell culture production
- Must have technical writing experience
For immediate consideration, please email a copy of your resume to firstname.lastname@example.org
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.