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Senior Quality Assurance Specialist

2 months ago

Tustin, California, United States Avid Bioservices Full time
About the Role

We are seeking a highly skilled Quality Assurance Sr. Specialist to join our team at Avid Bioservices. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and safety of our biopharmaceutical products.

Key Responsibilities
  • Review and approve discrepancy investigations, including deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results.
  • Ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.
  • Review and approve CAPA records.
  • Ensure accuracy of records and reports, including stability reports.
  • Advise production on proper documentation requirements as needed.
  • Review batch production records.
  • Review of Manufacturing forms and paperwork in association with Batch Production Records.
  • Maintain a state of inspection readiness.
  • Maintain company quality and safety standards.
  • Collaborate with Management to establish and meet targets and timelines.
  • Independently manage competing priorities with limited instruction.
  • Serve as a Quality representative on cross-functional and multi-site teams.
  • Identify and recommend solutions to potential procedure, process, and system gaps.
  • Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
  • Represent Quality Assurance on multi-disciplinary project teams.
  • Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
  • Perform tasks as requested by Management to support Quality oversight activities.
Requirements
  • B.A. or B.S. degree (preferably in Life Science).
  • 4+ years of Quality experience in the biopharmaceutical industry.
  • Strong knowledge of cGMP regulations.
  • Strong knowledge of root cause analysis processes and tools.
  • Must be able to gown for a class 10,000 cleanroom environment.
  • Ability to interpret Quality standards for implementation.
  • Skills to independently evaluate situations and propose potential solutions.
What We Offer

We offer a competitive compensation package, including a base salary, equity grants, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $87,400 to $116,600 annually, depending on experience and qualifications.

We also offer opportunities for career growth and development as well as a supportive and inclusive work environment.

About You

You will be a highly motivated and detail-oriented individual with excellent communication and interpersonal skills.

You will have a strong understanding of Quality Assurance principles and practices, as well as experience working in a fast-paced environment.

You will be able to work independently and as part of a team, with a strong focus on delivering high-quality results.

Physical Demands & Work Environment

This role requires a blend of regular activities such as sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds.

The work environment may expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally.

Reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting.

Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.