Quality Specialist 3 - Audits, Compliance and QMS

BioReliance Corporation•Rockville, MD

About The Position

This role is for a Quality Specialist 3 at MilliporeSigma, focusing on audits, compliance, and Quality Management Systems (QMS). The position involves conducting audits and reviewing/approving various regulated documentation. The company emphasizes innovation in science and technology across Healthcare, Life Science, and Electronics, and values a diverse workforce committed to enriching lives and caring for people, customers, patients, and the planet. External applicants must be eligible to work in the US as sponsorship is not offered.

Requirements

Bachelor’s Degree in a scientific field (e.g., Biology, Chemistry, Bioengineering, etc.) 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 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.