Quality Control Analyst

2 weeks ago

Rocklin, United States MilliporeSigma Full time

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 Control Analyst performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods ensuring compliance with established standards. This role supports the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, and local and global Quality Management Systems (QMS).
- Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards
- Participate in method validation and method transfer activities
- Conducts and validates various biological and chemical quality control (QC) assays
- Write, revise and/or review Standard Operating Procedures while adhering to regulatory requirements
- Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines
- Troubleshoot equipment problems
- Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process
- Maintain cGMP compliance in the laboratory
- May require work on various projects to improve efficiency or compliance
- Additional responsibilities may be assigned by Supervisor or Manager as needed to support the Organization
- Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDR, and compliance to the site Quality Manual Other duties as assigned

**Who You Are**:
**Minimum Qualifications**:
Bachelor’s Degree in Biology, Microbiology, Immunology, or other life science field

**Preferred Qualifications**:

- 3+ years’ experience in an FDA/ISO regulated environment
- Knowledge of FDA QSRs, cGMP, and ISO 13485 or other industry standards
- Knowledge and experience in IHC, ELISA, and Bioburden
- Knowledge of SAP and/or SAP NEXT
- Excellent communication skills, both written and verbal

RSREMD

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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

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