QA Specialist - Early Phase Biopharma

Avid Bioservices; Costa Mesa (CA); On-site; USD 93,670,000 - 117,081,000; Full time

Job summary

Avid Bioservices in Costa Mesa, CA is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance across manufacturing records and batch reviews. This individual contributor will maintain inspection readiness, support cross-functional teams, and help identify and resolve quality issues.

Key responsibilities include reviewing batch production records, supporting investigations, and helping implement department initiatives while collaborating with management to meet targets.

Qualifications

• B.A. or B.S. degree (preferably in the life science disciplines).
• At least 2 years of experience in the biopharmaceutical industry.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret quality standards for implementation.
• Skills to independently evaluate situations and propose potential solutions.
• Able to interpret quality standards for implementation.

Responsibilities

• Review Manufacturing Batch Production Records.
• Review of Manufacturing forms and paperwork in association with Batch Production Records.
• Assist in the release of API batches and lots.
• Assist with discrepancy investigations.
• Compilation and QA Review of all records in Batch history records.
• Review of testing documentation from Microbiology and Chemistry groups.
• Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
• Represent Quality Assurance on multi-disciplinary project teams.

Skills

Quality Assurance

cGMP knowledge

Attention to detail

Communication

Education

Bachelor's degree in life sciences

Job description

Avid Bioservices in Costa Mesa, CA is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance across manufacturing records and batch reviews. This individual contributor will maintain inspection readiness, support cross-functional teams, and help identify and resolve quality issues.

Key responsibilities include reviewing batch production records, supporting investigations, and helping implement department initiatives while collaborating with management to meet targets.