Previous Job
Previous
Quality Assurance Lead III
Ref No.: 15-03873
Location: Canton, Massachusetts
Knowledge of Government Contract execution and compliance with the Federal Acquisition Regulations (FARs)
Make sure that if you have a candidate, that the travel expenses you offer or agree to are in compliance with the FAR's
The fees charged and the invoices submitted to SP for the work/equipment shall be in conformance with the Federal Acquisition Regulation ( "FAR ) clauses attached to this Purchase Order and including FAR 31.205-46 (TRAVEL). If Per Diem is to be used, Daily Per Diem should be in conformance with the Federal Acquisition Regulations.

Review and approve validation protocols and final reports. Working closely with validation personnel to ensure that validation approach is compliant and supporting documentation is generated. Review and approve requalification/revalidation assessments and reports.
Review and approve Deviations and provide input on CAPAs and provide guidance on CAPA plans and change controls. Review and approve technical documents such as development reports as needed.
Review/ approve Change Control, Out of Trends stability, Supplier Corrective actions, Quality System Element documentation Prepare, review and approve controlled documents relevant to GxP operations Participate in cross functional teams related to internal/external audits and regulatory inspections Contribute via review of annual product review and updates for regulatory filing(s), as applicable

Skills:
The ability to coordinate multiple priorities in a fast paced environment Experience in maintaining CGMP compliance Solid organizational, analytical and problem solving skills Strong communication skills with the ability to interact with all levels throughout the organization In addition, demonstrated excellent interpersonal skills and flexibility Must have understanding and/or working knowledge of CGMP regulations The ability to Apply quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities The ability to Work effectively and efficiently in a cross functional team environment


Education:
Minimum of a B.S. in Biology, Chemistry, Microbiology or related field

Experience:
Must have a minimum of 5-7 years of relevant experience within Quality or Compliance
Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience.
Industry experience with aseptic operations preferred