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Sr. QA Specialist/Auditor - Life Sciences

Company: Azzur IT
Location: Allentown
Posted on: September 10, 2018

Job Description:

Our client, a Biotech leader seeks a talented Senior QA Specialist, to be responsible for assuring compliance for in-process and final product of Cell therapy manufacturing. The Sr QA Specialist will be managing Audits/Inspections as well as Quality Systems including Deviations, CAPA and product safety that impact on patient safety. Responsibilities include: Prepare and review SOPs and other documents for compliance and provide guidance to staff on raw material, in-process and finished product release activities and GMP/GTP Evaluate processes and conduct process improvement/root-cause analyses and facilitates implementation of corrective actions, conducting presentations/communications as needed. Develop and complete deliverables related to QA activities including performing internal/external audits and inspections to prepare for product commercialization/licensing Qualifications College degree in technical discipline or equivalent work experience and minimum of seven years of QA experience in an FDA related regulatory environment. Advanced degree a plus. Experience managing and conducting audits/inspections as well as Investigations. Proven organization, communication, analytic and interpersonal skills with strong initiative to effectively work in a team-based environment on multiple activities that are time sensitive. In-depth understanding of cGMP, FDA, GTP, CFR Part 820, 211, 1271 and other regulations related to tissue products manufacturing. Proficiency using computer software and systems related to performing QA activities such as Quality/Document Management systems, ERP, MES and other. Demonstrated proficiency of process improvement tools and techniques to analyze problems. This is a unique contract-to-hire opportunity to join a company currently working on a biologic product in a pre-commercialization/licensing stage, offering attractive benefits and bonus.

Keywords: Azzur IT, Allentown , Sr. QA Specialist/Auditor - Life Sciences, Accounting, Auditing , Allentown, Pennsylvania

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