Job Description

Job Description

Job Description

General Responsibilities:

The Quality Assurance Specialist is responsible for supporting the Quality Management Systems to ensure compliance with applicable regulatory and industry standards, quality improvement and efficiency for phase appropriate cGMP manufacture of biological products.

Responsibilities:

• Review of Manufacturing Batch Record documentation for accuracy, completeness and compliance with effective SOPs and to ensure the product is manufactured according to cGMP and regulatory requirements to meet quality standards
• Review and disposition of Drug Substance and Drug Product Injection lots [Disposition of supporting prepared media’s, process simulations]
• Quarantine of cryopreserved Drug Substance material
• Receipt of Quarantine Bulk Drug Substance vials for storage and distribution of Bulk Drug Substance vials for testing and/or manufacture
• Review and approval of Controlled Documentation
• Inspection and review of biopsies upon receipt at the site
• Oversight of Biopsy Kit packaging for shipment
• Oversight of final Drug Product packaging for shipment
• Issuance, review and approval of Deviations, Corrective and Preventative Actions (CAPAs), and Change Controls
• Support Quality Assurance Management, as needed
• Tracking and trending of Key Performance Indicators for Quality Assurance
• Conducting Quality on the Floor within the Aseptic Manufacturing and Quality Control Areas
• Monitor Quality Assurance programs and procedures to ensure compliance
• Write and revise Quality Systems SOPs as necessary to maintain compliance
• Oversight of Risk Assessment activities
• Support of Root Cause Analysis activities as part of the investigation process

Computer Skills

• Functional knowledge of Microsoft Office – Word, Excel, Teams and Outlook
• Experience with Master Control is considered a plus.
• Experience with asset management software is considered a plus.

Education:

• BS/in life sciences or related fields

Experience:

• Minimum 5 years in cGMP related experience (Or minimum 3 years in cGMP QA)
• Experience in Car-T and/or gene therapy manufacturing environment
• GCP experience is considered a plus.
• Experience in controlled document management processes
• Experience writing, reviewing and approving Deviations, CAPAs, Investigations and Change Controls and management of these items.
• Experience in aseptic processing and mammalian cell production is considered a plus.
• Working knowledge of cGMP and other government and industry standards
• Experience with Batch Record review, approval.
• Experience with controlled documentation review, approval
• Experience in a similar role in biologics or pharmaceutical industry a plus
• Leading group training activities.

Skills:

• Detail oriented
• Excellent verbal and written skills
• Good interpersonal communication skills
• Ability to independently drive quality compliance across functional teams
• Must be open to occasional off shift and weekend work
• Positive work attitude that supports teamwork and continuous improvement

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