Quality Specialist 3 - Compliance and QMS

Merck•Rockville, MD

13d

About The Position

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 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. Provide support for client regulatory submissions. Facilitate client audits, address client concerns and perform supplier audits. Review and approve client and supplier quality agreements. Review and approve validation files for systems and assays, and 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. Review and approve client and supplier quality agreements. Review and approve change control (GCC) records. 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.

Requirements

Bachelor’s Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.
2+ 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 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.
Provide support for client regulatory submissions.
Facilitate client audits, address client concerns and perform supplier audits.
Review and approve client and supplier quality agreements.
Review and approve validation files for systems and assays, and 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.
Review and approve client and supplier quality agreements.
Review and approve change control (GCC) records.
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.