Vacancy expired!
Job Title: Quality Assurance SpecialistLocation: Exton, PAType: Contract to hireSchedule: Monday-Friday 8AM-5PM Overview: Biotech Company is looking for an experience QA Specialist to join their team! In this position, you will play a key role in supporting the Manufacturing, Quality Control, and Facilities Teams to uphold rigorous standards and ensure the delivery of high-quality products. Responsibilities:
Review all Manufacturing Batch Records (Drug Substance/Drug Product/ Media Fills/ Prepared Media and Protocol Records).
Review and disposition of manufactured Bulk Drug Substance and Drug Product Injection lots. Records to be reviewed for accuracy, completeness and compliance with effective SOPs.
Ensure the strength, identity, safety, purity and quality of the product is never compromised.
Quarantine and Final Disposition of raw materials for 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 final product for shipment.
Assist the Quality Assurance Management in daily operations, as needed.
Conducting internal 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.
Conduct risk-based investigations through using problem solving tools.
Manage Deviations, Change Controls and CAPAs to closure.
Conduct External Audits after getting qualified per the qualification criteria.
Participate in continual improvement projects.
Participate in Regulatory Agency Inspections, as needed.
Requirements:
Bachelor’s degree (preferably in science)
Experience with in the Biotech/Pharmaceutical Industry in a Quality focused position
3-5 yrs experience in a quality role with quality management systems, batch record review, deviations, CAPAs, etc.
MasterControl experience a plus
Internal auditing experience a plus (FDA, ICH, ISO 9000) Experience in aseptic processing and mammalian cell culture production considered a plus
Familiarity 21CGR Part 210, 211, ISO 9001 Std and ICH guidelines is considered a plus
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
