Quality Specialist 1

Merck•Rockville, MD

4d•Onsite

About The Position

At MilliporeSigma, as the Quality Assurance Specialist 1, you will perform a variety of tasks within the Quality Assurance department, including conducting audits and the reviewing/approving 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 Review and approve deviation records and validation files for systems and assays Conduct laboratory inspections.

Requirements

Bachelor’s Degree in a scientific discipline (e.g., Biology, Biotechnology, Chemistry, etc.), OR a Bachelor’s Degree in a technical discipline (e.g., Computer Science, Information Technology, etc. )
6+ months work experience in GMP/GLP environment

Nice To Haves

Batch record review
Strong work ethic and quality of work
Experience meeting deadlines
Works with cross-functional teams and builds networks within QA and Operations departments
Open-minded and flexible
Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
Familiarity with International regulations (EMA, MHRA)
Strong verbal and written communication skills

Responsibilities

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
Review and approve deviation records and validation files for systems and assays
Conduct laboratory inspections