Quality Assurance Specialist 3

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

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 3, you will perform a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.

Essential Job Functions

• Review and approve standard operating procedures (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.

Who You Are

Minimum Qualifications

• Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.

Preferred Qualifications

• Experience reviewing batch records, event records, CAPAs and GCCs.
• Proficient knowledge and application 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.
• Open-minded, flexible and works with agility.
• Takes responsibility for ensuring that turnaround times are met.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.
• Willing to embrace and implement change on a global scale.

Pay Range for this position - $70,800 - $106,200

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

RSREMD

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!