QA Specialist 3: GMP Audits & CAPA Leader

MilliporeSigma; Rockville (MD); On-site; USD 71,000 - 106,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma, Rockville, MD, is seeking a Quality Assurance Specialist 3 to perform audits and review/approval of regulated documentation within a GxP environment. You will review SOPs, batch records, CAPAs, and deviations, and support regulatory inspections as part of a cross-functional QA team.

The role requires a Bachelor's degree in a scientific field and 4+ years QA experience, with strong knowledge of FDA/EU regulations, data integrity, and ethics.

Qualifications

• Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.
• Experience reviewing batch records, event records, CAPAs and GCCs.
• Proficient knowledge of FDA and EU regulations (cGMP, GLP, Data Integrity).
• Excellent communication and interpersonal skills.
• Acts ethically and ensures quality of own work and that of others.

Responsibilities

• Review and approve SOPs, laboratory / batch records, GMP part numbers, and other quality records.
• Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
• Review and approve deviations / OOS records of varying impact and criticality.
• Conduct trend analysis for deviations and review / approve applicable CAPA records.
• Conduct laboratory inspections to include commissioning and/or internal audits.
• Provide support for regulatory inspections.
• Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.

Skills

GxP experience

QA in pharmaceutical

Regulatory knowledge

Communication skills

Education

Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field

Job description

MilliporeSigma, Rockville, MD, is seeking a Quality Assurance Specialist 3 to perform audits and review/approval of regulated documentation within a GxP environment. You will review SOPs, batch records, CAPAs, and deviations, and support regulatory inspections as part of a cross-functional QA team.

The role requires a Bachelor's degree in a scientific field and 4+ years QA experience, with strong knowledge of FDA/EU regulations, data integrity, and ethics.