GMP/GLP QA & Audit Lead

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

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in Rockville, MD, seeks a Quality Specialist 3 to provide independent quality oversight in a GMP/GLP laboratory setting. You will ensure regulatory and client requirements are met through investigations, risk-based decisions, and continual improvement within a robust QMS.

Collaborative with operations, technical and client teams, this role enhances inspection readiness. The role requires a life sciences degree and 2+ years in QA audits or CAPA handling.

Qualifications

• Auditing experience in QA or regulatory environments.
• Root cause analysis and CAPA handling experience.
• Ability to interpret regulatory requirements and guide operations.

Responsibilities

• Lead or support client, internal, regulatory audits and inspections.
• Lead audit preparation, responses, and tracking of corrective actions.
• Drive inspection readiness and monitor audit commitments and CAPAs.
• Review and approve deviations, investigations, CAPAs, and risk assessments.
• Provide SME guidance on root cause analysis and quality investigations.
• Interpret regulatory requirements and advise operational teams.
• Review SOPs and GMP records, and support quality documentation.
• Facilitate risk assessments using HACCP and FMEA.
• Monitor quality metrics and drive continuous improvement initiatives.
• Support regulatory submissions, supplier qualification, and quality agreements as needed.

Skills

Auditing

CAPA management

Education

Bachelor's degree in life sciences

Job description

MilliporeSigma in Rockville, MD, seeks a Quality Specialist 3 to provide independent quality oversight in a GMP/GLP laboratory setting. You will ensure regulatory and client requirements are met through investigations, risk-based decisions, and continual improvement within a robust QMS.

Collaborative with operations, technical and client teams, this role enhances inspection readiness. The role requires a life sciences degree and 2+ years in QA audits or CAPA handling.