Quality Specialist 1
About the role
At MilliporeSigma, as the Quality Assurance Specialist 1, you will perform a variety of tasks within the Quality Assurance department, including conducting audits and reviewing/approving of various types of regulated documentation.
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
Requirements
- Bachelor’s Degree in a scientific discipline (e.g., Biology, Biotechnology, Chemistry, etc.), OR a Bachelor’s Degree in a technical discipline (e.g., Computer Science, Information Technology, etc.)
- 6+ months work experience in GMP/GLP environment
Preferred Qualifications
- Batch record review
- Strong work ethic and quality of work
- 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
Pay
Pay Range for this position - $28/hr - $43/hr
Benefits
- Health insurance
- Paid time off (PTO)
- Retail contributions
- Other perquisites
What we offer
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!