We are seeking a highly motivated Quality Assurance Specialist II to support Quality Assurance Operations in a fast-paced biologics manufacturing environment. This role will provide QA oversight and approval for deviations, OOS investigations, CAPAs, change controls, and other quality events while ensuring compliance with applicable GMP and regulatory requirements.

Key Responsibilities:

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  Provide QA oversight and approval for deviations, OOS investigations, change controls, CAPAs, and event records of moderate to significant complexity.
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  Ensure quality records are properly initiated, investigated, documented, and closed within established timelines.
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  Ensure appropriate escalation of deviations and quality issues in accordance with established procedures.
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  Support resolution of in-process product, final product, manufacturing, environmental, facility, equipment, and material-related quality issues.
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  Identify opportunities to improve the efficiency and effectiveness of deviation and CAPA processes while maintaining compliance.
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  Collaborate with Manufacturing, Quality Control, Engineering, and other cross-functional teams to resolve quality issues.
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  Support QA activities during manufacturing campaigns, including occasional weekend or night work as needed.
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  Maintain compliance with internal quality procedures and applicable U.S. and EU GMP regulations.

Required Qualifications:

Candidates should meet one of the following educational and experience requirements:

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  Master's degree in Biological Sciences or a related field; or
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  Bachelor's degree with 2+ years of relevant experience; or
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  Associate degree with 4+ years of relevant experience; or
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  High School diploma with 5+ years of relevant experience.

Preferred Qualifications:

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  Experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
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  Quality Control background in Analytical, Virological, or Microbiological testing.
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  Experience with Deviation Management, OOS Investigations, CAPA, Change Control, and Quality Event investigations.
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  Working knowledge of cGMP requirements and U.S. and EU regulatory standards.
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  Strong investigation, problem-solving, documentation, and risk-assessment skills.