Early Phase QA Specialist — Onsite (Biopharma)

Avid Bioservices, Inc.; Costa Mesa (CA); Presencial; USD 45.000 - 56.000; Tempo integral

Benefícios oferecidos por esta vaga

Health, dental, and vision insurance

401(k) matching

Paid time off

Resumo da vaga

Avid Bioservices, Inc. is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance and drive QA excellence in a fast-paced biopharma CDMO setting.

The role focuses on inspection readiness, batch review, and cross-functional collaboration to continuously improve processes and documentation. The candidate will partner with management to meet timelines, support excursions and investigations, and act as a subject matter expert for QA in manufacturing and related testing

Qualificações

• BA/BS degree in life sciences required.
• 2+ years in biopharma industry ideal.
• Knowledge of cGMPs or equivalent regulations preferred.
• Ability to interpret quality standards for implementation.
• Ability to independently evaluate situations and propose solutions.

Responsabilidades

• Maintain state of inspection readiness.
• Serve as QA representative on cross-functional teams.
• Review Manufacturing Batch Production Records and related forms.
• Assist in release of API batches and investigation of discrepancies.
• Provide QA oversight to internal and external customers.
• Generate departmental performance metrics for management review.

Conhecimentos

BA/BS degree

2+ years biopharma

cGMP knowledge

Interpret quality standards

Independent problem solving

Quality assurance

Formação

Bachelor's degree in life sciences

Descrição da vaga

Avid Bioservices, Inc. is seeking a Quality Assurance Specialist (Early Phase) to ensure cGMP compliance and drive QA excellence in a fast-paced biopharma CDMO setting.

The role focuses on inspection readiness, batch review, and cross-functional collaboration to continuously improve processes and documentation. The candidate will partner with management to meet timelines, support excursions and investigations, and act as a subject matter expert for QA in manufacturing and related testing