Quality Assurance Specialist 2

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

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

As the Quality Assurance Specialist 2, you will support our Contract Testing Services by 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. You will work collaboratively with various teams including QA and Operations to support compliance and maintain quality standards while developing proficiency in quality systems and regulatory requirements.

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 facilitating 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.

Support maintenance of SOPs and adherence to global regulatory (e.g., FDA, EMA) and internal requirements.

Ensure accuracy, completeness, and compliance of documentation.

Who You Are:

Minimum Qualifications:

Bachelor’s Degree in any discipline with 2+ years' experience in Quality Assurance in a science field ora GxP environment.

OR

Associate’s Degree in any discipline with 4+ years in a Quality Assurance in a science field or GxP environment

OR

High school diploma or GED with6+ years in a Quality Assurance in a science field or GxP environment

Preferred Qualifications:

Practical knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines.

Familiarity with International regulations (EMA, MHRA).

Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).

Strong communication and interpersonal skills.

Acts ethically and ensures quality of own work and that of others.

Open-minded, flexibility and works with agility.

Ensures deadlines are met by taking initiative.

Works with cross-functional teams and builds networks within QA and Operations departments.

Collaborates with various teams to identify and implement improvements.

Pay Range for this position - $28/hr – 43/hr

Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!