Quality Assurance Specialist 3

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

25d

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 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 within a GxP environment.
Associate Degree in Biology, Chemistry, Engineering, or other scientific field with 6+ years' experience in quality within a GxP or regulated field.
High School Diploma or GED with 8+ years' experience in quality within a GxP or regulated field.

Nice To Haves

Experience with root cause analysis
Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
Experiencd in client audit programs and or supplier audits
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

Conduct 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.