Senior Quality Assurance Representative
MilliporeSigma Canada Ltd.
Summary
This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility.
Job description
Responsibilities Include But Are Not Limited To
- 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 10am - 6:30pm.
Physical Attributes
- Lift and/or move up to 25 pounds.
- Wear appropriate Personal Protective Equipment.
Who You Are
Minimum Qualifications:
- Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience.
- OR
- High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience.
Preferred Qualifications
- 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.
Requirements
- Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience.
- OR High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience.
- 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.
Benefits
- Health Insurance
- Paid Time Off (PTO)
- Retirement Contributions
Company overview
MilliporeSigma Canada Ltd. is the Canadian subsidiary of Merck KGaA, Darmstadt, Germany, operating as the life science business in the United States and Canada. As part of one of the world's oldest pharmaceutical and chemical companies with over 350 years of history, MilliporeSigma offers one of the broadest portfolios in the life science industry, featuring more than 300,000 products and solutions. The company specializes in providing essential tools, services, and expertise for scientific research, drug discovery and development, bioprocessing, and diagnostics. With over 21,000 employees globally across 59 manufacturing and testing sites, MilliporeSigma combines the legacy expertise of EMD Millipore and Sigma-Aldrich to deliver leading-edge technologies for laboratory filtration, lab water systems, bioscience applications, and bioprocessing solutions. The Canadian operations, headquartered in Oakville, Ontario, serve as a critical distribution and support hub for researchers and pharmaceutical manufacturers across Canada, enabling scientific breakthroughs through reliable access to high-quality products and technical expertise.