Quality Systems Specialist - CAPA & Controls Expert

Avid Bioservices; Tustin (CA); On-site; USD 58,120 - 77,214; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Performance-based bonuses

Job summary

Avid Bioservices is seeking a Sr. Specialist, Quality Systems in Tustin, CA to provide technical reviews of Quality Management System discrepancy reports and CAPAs. The role demands authoring and editing critical quality documents, ensuring compliance with regulations. Candidates require a B.A. or B.S. in life sciences and 4–5 years in the biopharmaceutical industry. A competitive compensation range from $42.19 to $56.05 hourly is offered with extensive benefits and a positive team-oriented work environment.

Qualifications

• 4–5 years of experience in the biopharmaceutical industry, preferably with biologics.
• Knowledge of cGMPs or equivalent regulations.
• Ability to independently evaluate situations and propose solutions.

Responsibilities

• Provide technical review of Quality Management System discrepancy reports.
• Author and approve discrepancy reports, CAPA records, and controlled documents.
• Maintain a state of inspection readiness and participate in inspection preparation.

Skills

Technical writing and editing skills

Knowledge of cGMPs

Ability to interpret Quality standards

Experience with quality systems software

Problem-solving skills

Attention to detail

Excellent communication skills

Experience with deviation records

Education

B.A. or B.S. degree in life sciences

Job description

Avid Bioservices is seeking a Sr. Specialist, Quality Systems in Tustin, CA to provide technical reviews of Quality Management System discrepancy reports and CAPAs. The role demands authoring and editing critical quality documents, ensuring compliance with regulations. Candidates require a B.A. or B.S. in life sciences and 4–5 years in the biopharmaceutical industry. A competitive compensation range from $42.19 to $56.05 hourly is offered with extensive benefits and a positive team-oriented work environment.