Job title: Sr. Quality Assurance Specialist
Location:Swiftwater, PA (Onsite)
Experience: 6+ years
Contract Duration: 12+ Months Contract
Job Summary
This onsite contract role calls for an experienced Sr. Quality Assurance Specialist with a strong background in pharmaceutical or biopharma manufacturing. The work centers on supporting vaccine and viral antigen production, leading CAPA activities, and ensuring full compliance with GMP quality systems. You'll partner with cross-functional teams, manage multiple projects under tight deadlines, and maintain high standards across all quality operations. A solid grasp of biotech processes, strong documentation skills, and proficiency with systems like LIMS, TrackWise, and SAP are key to succeeding here.
Key Responsibilities
Lead and oversee quality activities across biotech and vaccine manufacturing operations, with a focus on viral antigen production.
Drive CAPA efforts from initiation through closure, ensuring thorough root-cause analysis and effective preventive actions.
Maintain strong alignment with GMP Quality System Regulations and support continuous inspection readiness.
Partner closely with cross-functional teams including Manufacturing, Validation, Engineering, QC, and Supply Chain to troubleshoot issues and strengthen quality processes.
Review and approve documents related to manufacturing, validation, deviations, change controls, and batch records.
Support audits and regulatory interactions as needed.
Manage multiple projects at once while meeting strict timelines.
Utilize LIMS, TrackWise, SAP, and other quality-related systems for documentation, data tracking, and compliance.
Required Experience
Minimum 6 years of experience in pharmaceutical, biopharmaceutical, or related manufacturing environments.
Working knowledge of biotech manufacturing, especially viral antigen production.
Hands-on experience with vaccine-related processes is essential.
Proven competency in GMP quality systems and regulatory expectations.
Strong background leading CAPA activities.
Proficiency with quality and validation software tools such as LIMS, TrackWise, and SAP.
Ability to juggle multiple tasks and deliver within strict timelines.
Experience working with cross-functional teams.
Education
Bachelor's degree in engineering, life sciences, biotechnology, or a technical field required.
Master's degree preferred.
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