Early-Phase QA Specialist – Biopharma Onsite

Avid Bioservices

Costa Mesa (CA)

On-site

USD 4,531,000 - 5,629,000

Full time

14 days+
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Job summary

Avid Bioservices in Costa Mesa, CA, is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance and support manufacturing and release activities.

You will maintain inspection readiness, review batch production records, assist investigations, and collaborate with cross-functional teams to drive quality and timely product delivery. This onsite role offers competitive pay and benefits.

Qualifications

  • B.A. or B.S. degree in life sciences.
  • At least 2 years of biopharmaceutical industry experience.
  • Knowledge of cGMPs or equivalent regulations.
  • Ability to interpret quality standards for implementation.
  • Strong analytical and problem-solving skills.

Responsibilities

  • Maintain a state of inspection readiness.
  • Serve as Quality representative on cross-functional and multi-site teams.
  • Review Manufacturing Batch Production Records.
  • Assist with discrepancy investigations.
  • Review testing documentation from Microbiology and Chemistry groups.
  • Represent QA on multi-disciplinary project teams.
  • Provide Quality oversight to internal and external customers.

Skills

cGMP knowledge
Quality assurance
Problem solving
Documentation
Communication skills

Education

Bachelor's in Life Sciences

Tools

GxP systems

Job description

Avid Bioservices in Costa Mesa, CA, is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance and support manufacturing and release activities.

You will maintain inspection readiness, review batch production records, assist investigations, and collaborate with cross-functional teams to drive quality and timely product delivery. This onsite role offers competitive pay and benefits.

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