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Location

Exton, PA | United States

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Job description

Job Title: Quality Assurance Specialist

Location : Exton, PA

Type: Contract to hire

Schedule: 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. 

#M3

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