Quality Assurance Representative
About The Position
Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility.
Requirements
- Bachelors Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering Discipline.
- OR
- High School Diploma or GED and 2+ years of GMP pharmaceutical industry experience.
Nice To Haves
- Experience with computer software applications including Microsoft Excel, Word, and Access.
- Experience with Quality Management computer systems and SAP.
- Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning.
Responsibilities
- Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed.
- Performs and documents line clearances and room release for manufacturing use.
- Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented.
- Monitors the formulation and filling processes to ensure cGMP compliance.
- Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators. Requires qualification in aseptic gowning and certification as an aseptic processing SME.
- Observers, reports, and documents operator cleaning and disinfection practices.
- Documents, reports, and trends observations stemming from Quality Oversight.
- Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices.
- Monday - Friday 8am - 4:30pm
Benefits
- Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
