QA Data Reviewer – GMP & Data Integrity Focus

avidbio; Tustin (CA); On-site; USD 45,000 - 56,000; Full time

Job summary

Avid Bioservices in California seeks a Data Reviewer, Quality Assurance, to verify that values in draft reports match the primary source data and to flag discrepancies. This full-time onsite role requires meticulous attention to detail.

Duties include GMP review of validation protocols, reports, and test methods; data integrity checks under 21 CFR; and support for investigations. Compensation ranges from $32.69 to $40.86 per hour plus benefits; schedule is Monday–Friday with overtime when needed.

Qualifications

• Bachelor’s degree in a life sciences field (biology, microbiology, biochemistry, chemistry)
• 4+ years’ work experience in a GMP/biopharmaceutical/pharmaceutical manufacturing environment
• Knowledge of cGMPs or equivalent regulations is preferred
• Experience with 21 CFR data integrity requirements; ability to evaluate situations and propose solutions
• Excellent technical writing and editing skills

Responsibilities

• Perform a thorough review of data, including electronic data and documents to ensure compliance with applicable specifications and/or protocols
• Conduct GMP review of Validation/Qualification Protocols, Reports, and other GMP documents for data correctness
• Conduct GMP review of Method Validation, Test Methods, and associated forms
• Conduct GMP review of electronic data to ensure compliance with data integrity policies
• Support data verification of OOS/OOT investigations, as assigned
• Support data verification of QE investigations, as assigned
• Support review of procedural and method revisions, as assigned
• Performs other duties as assigned to support Quality activities

Skills

Attention to detail

Multitasking

Technical writing

Education

Bachelor's degree in life sciences

Job description

Avid Bioservices in California seeks a Data Reviewer, Quality Assurance, to verify that values in draft reports match the primary source data and to flag discrepancies. This full-time onsite role requires meticulous attention to detail.

Duties include GMP review of validation protocols, reports, and test methods; data integrity checks under 21 CFR; and support for investigations. Compensation ranges from $32.69 to $40.86 per hour plus benefits; schedule is Monday–Friday with overtime when needed.