Quality Specialist 2
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: The Quality Specialist 2 contributes or impacts the results of the Quality Assurance (QA) team and is accountable for the quality of work. This role performs a variety of tasks within the Quality Assurance department including conducting audits and review/approval of various types of regulated documentation. Job duties include: Shift: Monday-Friday 12:00pm to 8:30pm includes a shift differential Receives guidance from senior roles while independently solving low-complexity problems by analyzing information and selecting appropriate solutions.
Requirements
- Bachelor’s Degree in Biology, Chemistry, or other science discipline with 2 + years of Quality Assurance experience in a GxP environment
- OR
- Associate Degree in in Biology, Chemistry, or other science discipline with 4 + years of Quality Assurance experience in a GxP environment
- OR
- High School Diploma or GED with 6 + years of Quality Assurance experience in a GxP environment
Nice To Haves
- Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
- Demonstrates strong communication and interpersonal skills, acts ethically to ensure quality in personal and teamwork, exhibits flexibility and agility, and takes responsibility for meeting turnaround times.
- Collaborates with cross-functional teams and builds networks within QA and Operations to identify and implement improvements.
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 validation files for assays, as well as minor, major, and critical impact deviations and OOS records.
- Conduct trend analysis for deviations and review / approve applicable CAPA records.
- Conduct laboratory inspections to include commissioning and/or internal audits.
- Provide support for client regulatory submissions, client audits and supplier audits.
- Review and approve client and supplier quality agreements.
- Involves up to 10% travel
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
Mid Level
