Quality Specialist 3

Merck•Rockville, MD

About The Position

At MilliporeSigma, as a Quality Assurance Specialist 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 root cause 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. 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 internal audits and assay methods. 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 Assurance within a GxP environment.
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 root cause 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
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 internal audits and assay methods
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