Quality Specialist II - OOS Deviation & Compliance

Dawar Consulting•El Segundo, CA

4d•Onsite

About The Position

Our client, a global leader in biotechnology, is seeking a highly motivated "Quality Specialist II" based at El Segundo, CA. 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 in a fast-paced biologics manufacturing environment.

Requirements

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

Nice To Haves

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

Responsibilities

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