Quality Assurance Specialist
4 weeks ago
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Beacon Hill. As a Quality Assurance Specialist, you will be responsible for performing testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein, and cell-based assays.
Key Responsibilities:
- Execute analytical test methods for bulk intermediate testing and final product release testing.
- Execute testing for raw materials.
- Participate in authoring, reviewing, and revising QC SOPs and other technical documents as necessary to maintain compliance.
- Review quality control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity, and quality of the product.
- Timely response to out-of-specification results, including notification to area supervision.
- Communicate with individual operations departments (manufacturing, quality assurance, facilities) to ensure that company objectives are met on schedule.
- Maintain housekeeping in the laboratories.
- Assist the quality control supervisor in daily operations, as needed.
- Perform growth promotion testing on prepared media.
- Direct sterile media fill trials and perform support testing.
- Authoring and/or executing protocols and generating technical reports.
- Analytical method validation.
- Equipment qualification.
- Training of other employees.
- Completion of thorough laboratory investigation reports (LIRs) to ensure that potential problems and root causes are identified, impact assessed, and actions to prevent recurrence are considered and implemented.
Requirements:
- Bachelor of Science degree in a relevant scientific discipline, such as biochemistry, chemistry, molecular biology.
- Advanced degree (masters or doctorate) in a relevant scientific discipline, such as biochemistry, chemistry, molecular biology.
- 3-5 years quality control experience in a similar role in the biologics or pharmaceutical industry.
- 2-3 years experience in mammalian cell culture in an academic or industrial laboratory.
- Knowledge of basic laboratory skills (including aseptic technique, etc.) are required.
- Knowledge of current good manufacturing practice and industry standards.
- Experience with analytical technical transfer is preferred.
- Familiarity with analytical equipment including PCR, UV absorbance plate readers, flow cytometers, microscopes, and pH meters.
- Experience in aseptic processing and mammalian cell culture.
- Excellent verbal and written skills.
- Good interpersonal communication skills.
- Must be open to occasional off-shift and weekend work.
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