Quality Assurance Specialist
MilliporeSigma Canada Ltd.
Summary
MilliporeSigma has an opening as a Quality Assurance (QA) Specialist at our Round Rock location. In this role you will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements. Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods.
Job description
Your Role
MilliporeSigma has an opening as a Quality Assurance (QA) Specialist at our Round Rock location. In this role you will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements. Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods.
- Perform document record review and approval of batch records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.
- Generating and review Certificate of Analysis (CoA) for catalog and custom projects.
- Generate quarterly metrics summarizing documentation review and production activities.
- Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements.
- Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents.
- Support rollout of local and corporate initiatives.
Who You Are
Minimum Qualifications
Bachelor's Degree in Chemistry, Biology, or other Life Science discipline.
Preferred Qualifications
- Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001.
- Knowledge of quality system requirements of the pharmaceutical and/or clinical industries.
- Excellent communication skills. The ability to respond to colleagues effectively, both verbally and in writing. The ability to interact and work well with other team members.
- Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts.
- Self-motivated and able to work independently.
Requirements
- Bachelor's Degree in Chemistry, Biology, or other Life Science discipline
- Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001
- Knowledge of quality system requirements of the pharmaceutical and/or clinical industries
- Excellent verbal and written communication skills
- Ability to interact and work well with other team members
- Strong technical knowledge base
- Self-motivated and able to work independently
Benefits
- Health Insurance
- Paid Time Off
- 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.