QA Specialist II – cGMP/GLP Compliance & Audits

MilliporeSigma; Rockville (MD); On-site; USD 39,000 - 59,000; Full time

Benefits offered by this job

Medical insurance

401(k) matching

Paid time off

Job summary

MilliporeSigma in the United States is seeking a Quality Assurance Specialist 2 to support Contract Testing Services, ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements.

This role performs routine to moderately complex quality tasks under supervision and is responsible for executing quality systems activities, including document review, investigations, and audit support.

Qualifications

• Bachelor’s Degree with 2+ years in QA in a science field or GxP environment.
• Associate’s Degree with 4+ years in QA in a science field or GxP environment.
• High school diploma with 6+ years in QA in a science field or GxP environment.

Responsibilities

• Review and approve controlled quality documents, including SOPs, laboratory and batch records, and other quality records.
• Review and approve events/deviations, out-of-specification investigations, CAPAs, and change controls under appropriate oversight.
• Participate in root cause analysis using approved problem-solving tools and methodologies.
• Review study-related documents (e.g., protocols, technical specifications, data, certificates of analysis).
• Support customer audits by coordinating laboratory tours and document reviews.
• Support continuous improvement initiatives to enhance quality and compliance.
• Conduct internal audits and systems inspections in accordance with applicable cGMP/GLP requirements.
• Review and approve audit responses and applicable follow-up actions or CAPAs within assigned authority and under appropriate oversight.

Skills

Communication skills

Interpersonal skills

Attention to detail

Ethical conduct

Education

Bachelor’s Degree

Associate’s Degree

High school diploma or GED

Job description

MilliporeSigma in the United States is seeking a Quality Assurance Specialist 2 to support Contract Testing Services, ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and applicable regulatory requirements.

This role performs routine to moderately complex quality tasks under supervision and is responsible for executing quality systems activities, including document review, investigations, and audit support.