Quality Assurance Specialist 1

Merck KGaA Darmstadt Germany • Rockville, MD

116d • $30 - $49

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.

Requirements

• Bachelor's Degree in any discipline
• 6+ months' work experience in GMP/GLP environment

Nice To Haves

• 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

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

What This Job Offers

• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree