GxP QA Specialist II – Compliance & Audits

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

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

Life insurance

401(k) matching

Paid time off

Paid holidays

Incentive compensation

Job summary

MilliporeSigma in Rockville, MD is seeking a Quality Assurance Specialist 2 to support Contract Testing Services by ensuring cGMP and GLP compliance across quality systems. This role performs routine to moderately complex tasks under supervision, including document review, investigations, and audit support.

You will collaborate with QA and Operations teams to maintain standards, review SOPs and study documents, and assist with customer audits and continuous improvement initiatives.

Qualifications

• 2+ years' experience in Quality Assurance in a science field or GxP environment.
• Familiarity with cGMP/GLP regulatory expectations.
• Ability to review SOPs, investigations, CAPAs, and audit records.
• Strong written and verbal communication.

Responsibilities

• Review and approve controlled quality documents, SOPs and batch records.
• Review events/deviations, investigations, CAPAs, and change controls.
• Participate in root cause analysis using approved tools.
• Support customer audits by coordinating laboratory tours and document reviews.
• Conduct internal audits and support quality systems improvements.

Skills

Quality Assurance

cGMP knowledge

GLP compliance

Documentation review

Root cause analysis

Education

Bachelor’s Degree in any discipline

Associate’s Degree in any discipline

High school diploma or GED

Job description

MilliporeSigma in Rockville, MD is seeking a Quality Assurance Specialist 2 to support Contract Testing Services by ensuring cGMP and GLP compliance across quality systems. This role performs routine to moderately complex tasks under supervision, including document review, investigations, and audit support.

You will collaborate with QA and Operations teams to maintain standards, review SOPs and study documents, and assist with customer audits and continuous improvement initiatives.