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US-CA-Redwood: Quality Assurance Manager in Biotech

Date: 02-Apr-2015
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Quality Assurance Manager in Biotech

Responsibilities will include:

· Involving yourself in the management of Quality Systems to assure GMP compliance and product quality of manufacturing activities at the suppliers for Recothrom

· The evaluation of QA Records and management of GMP Compliance, and the oversight of technical reviewers for:

o Drug Master Batch Records and executed batch records

o Compliance documents

o Disposition of Recothrom lots for clinical and commercial distribution.

· Reviewing Change Control Requests (CCR) associated with Recothrom and the coordination/tracking of CCR implementation actions

· Contributing to the Supplier (Contract Manufacturing/testing and Raw Material/Components) Qualification and oversight program, and perform supplier audits

· Collaboration with Document Control for timely document reviews and participate as a QA approver for documents such as Recothrom supplier deviation


· The disposition of Recothrom lots for clinical and commercial distribution

· The successful Management of GMP Quality Systems

· Leading the audit of quality systems and the regulatory compliance status of manufacturing facilities

· Expert Supplier Quality oversight

· Generation of QA documentation such as SOPs, investigational reports Taking pride in aligning your personal purpose with a company that believes its greatest priority is to save lives

Desired skills and experience:

· A minimum of 7 years’ experience in the pharmaceutical and/or biotechnology industry

· 5+ years’ experience in pharmaceutical and recombinant protein/biologics quality organizations

· A BA or BS in a Life Science or technical area

· Proficiency in the management of GMP Quality Systems

· Expertise in working with domestic and international manufacturing sites and affiliates with respect to US FDA pharmaceutical regulations

· Proven experience in Supplier Quality oversight

· Ability to generate QA documentation such as SOPs and investigational reports

· Sound computer skills with MS Word, Excel, Power Point a nd Visio

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center