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Job Requirements of Quality Assurance Audit Manager:
-
Employment Type:
Contractor
-
Location:
East Windsor, NJ (Onsite)
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Quality Assurance Audit Manager
Careers Integrated Resources Inc
East Windsor, NJ (Onsite)
Contractor
Quality Assurance Manager
Location: East Windsor, NJ
Duration: Perm/Direct Hire Role
Shift: General Shift
Pay: $110 to $120k annually with benefits
Job overview:
Qualifications - Skills & Requirements:
Must Have:
Location: East Windsor, NJ
Duration: Perm/Direct Hire Role
Shift: General Shift
Pay: $110 to $120k annually with benefits
Job overview:
- This position is responsible for product and vendor management of sterile and non-sterile contracted drug product and API manufacturers, packagers, testing labs, raw material manufacturers and distribution of commercial and clinical product, as a virtual manufacturer. This position has full product lifecycle oversight and is responsible for product disposition, the review and approval of batch records and testing records, specifications, review and approval of deviations, OOS and customer complaint investigations, including associated CAPA, change controls (manufacturing, testing, other) review and approval of validation protocols and reports, (manufacturing; packaging; test methods), equipment and facility qualification protocols and reports, and label approval.
- This position reports directly to the Sr. Manager of Quality Assurance.
- There are no direct reports with respect to this position.
Responsibilities:
- Quality Assurance CMC Responsibilities:
- Oversee contracted organizations for the manufacturing/packaging/ testing/ distribution of raw material through finished product (validation, process and method transfers, MBR, etc.)
- Oversee Contracted Testing Organizations; submit purchase requests; identify budget requirements
- Consolidate, review & approve Certificates of Analysis
- Review/Approve deviations/OOS
- Conduct investigations and write investigation reports for deviations from procedures.
- Author/Review SOPs, specifications and work instructions to ensure internal processes conform to GMPs and regulations.
- Manage vendor change controls and coordinate with Marketing Partners
- Perform Batch Record Review & Disposition of API, Intermediates and Finished Drug Products.
- Manage stability program & reference standards
- Perform trend analysis of data from stability program and lot release testing when necessary.
- Perform risk assessment of non-conformances and change controls having potential impact on product quality.
- Author Annual Product Reviews (APRs)
- Report monthly metrics and consolidate/trend stability data for APRs
- Manage Product Complaints for respective products
- Author/Revise Quality Agreements
- Technical Support for marketing partners
- Support client/regulatory audits/inspections.
- May assist with audits of contracted facilities.
Qualifications - Skills & Requirements:
- Attention to detail; well organized
- Strong computer skills
- Proficient in Microsoft Office Systems, Oracle a plus
Must Have:
- Bachelor’s Degree in pharmacy, chemistry, biology or microbiology or related field
- 5+ years experience in the Pharmaceutical Industry
- Biopharmaceutical experience a plus
- Sterile quality experience; firm understanding of Annex 1 preferred
- CRO experience preferred
- ASQ Certification preferred
- Travel up to 5% is a possibility both domestic and international
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