Quality Assurance Specialist - QMS & Compliance

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

About The Position

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: At MilliporeSigma, as a Quality Assurance 3, your tasks will include conducting audits and review/approval of various types of regulated documentation. Review and approve RCA analysis for robustness and accuracy and/or perform robust RCA using various RCA tools and act as the Subject Matter Expert for RCA. Train and/or provide peer mentorship in the rootcause Investigative Process and techniques. Analyze and evaluate information captured through investigations, communicate findings and recommendations Review and approve OOS, trend, critical-impact deviations and lower impact deviations and conduct trend analysis for deviations. Review / approve applicable CAPA records and conduct Effectiveness checks. Review and approve change control (GCC) records. Train Quality Specialists and/or Operations teams on quality topics. Perform client audits and supplier audits and review and approve client and supplier quality agreements. Provide support for regulatory inspections and for client regulatory submissions. Act as Quality SME during regulatory inspections and customer audits for areas of expertise. Conduct laboratory inspections to include commissioning and/or internal audits. Author, review and approve standard operating procedures (SOPs), quality policy documents. May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records. May 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. May review and approve validation files for systems and assays. Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics. May perform risk assessment using various methodologies.

Requirements

Bachelor’s Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assrance within a GxP environment.
1+ years' experience with conducting client and/or supplier audits in a Quality Assurance role.
1+ years' experience in conducting and/or reviewing root cause analysis and CAPA for deviations and out-of-specification (OOS) results in a Quality Assurance role

Nice To Haves

Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
Excellent communication and interpersonal skills.
Ensures quality of own work in an ethical manner.
Open-minded, flexible and works with agility.
Meets assigned deadlines.
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.

Responsibilities

Conducting audits and review/approval of various types of regulated documentation.
Review and approve RCA analysis for robustness and accuracy and/or perform robust RCA using various RCA tools and act as the Subject Matter Expert for RCA.
Train and/or provide peer mentorship in the rootcause Investigative Process and techniques.
Analyze and evaluate information captured through investigations, communicate findings and recommendations Review and approve OOS, trend, critical-impact deviations and lower impact deviations and conduct trend analysis for deviations.
Review / approve applicable CAPA records and conduct Effectiveness checks.
Review and approve change control (GCC) records.
Train Quality Specialists and/or Operations teams on quality topics.
Perform client audits and supplier audits and review and approve client and supplier quality agreements.
Provide support for regulatory inspections and for client regulatory submissions.
Act as Quality SME during regulatory inspections and customer audits for areas of expertise.
Conduct laboratory inspections to include commissioning and/or internal audits.
Author, review and approve standard operating procedures (SOPs), quality policy documents.
May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
May 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.
May review and approve validation files for systems and assays.
Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.
May perform risk assessment using various methodologies.