Senior Quality Assurance Associate, QA Product Release

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Merck Group is seeking a Senior Quality Assurance Associate for QA Product Release to evaluate materials and finished goods, ensure compliance with analytical, packaging and labeling specs, and lead risk assessments across supplier and product life cycles. The role is on site in St. Louis with 70 to 90% office time and 10 to 30% production work. Candidates should have a degree in life science or engineering with 2+ years in the life sciences, or 5+ years QA experience; preferred knowledge of ISO 9001/13485 and regulatory issues (FDA, USDA, ICH, EDQM, IVDR) and familiarity with SAP or Trackwise. To apply, tailor your resume to release, risk mitigation, and regulatory work; demonstrate strong writing and multitasking skills. Sponsorship not available.

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. 

The key responsibilities of a Quality Assurance Senior Associate, QA-Product Release include the

following:

• Evaluate raw material or final product (repack or manufactured) supply chain to determine
• acceptability to meet import/export requirements that were derived from animal by-product
• (ABP).
• Ensure that all aspects of routine product assignment and release for raw materials and finished goods meet analytical, packaging, and labeling specifications in accordance with establishedquality systems and regulatory/industry requirements.
• Technical/consultative expert for risk assessment evaluations & implementation of mitigation strategies related to; pathogenic agents, sourcing origin, genetically modified organisms, residual solvents, and/or heavy metals within the supply chain.
• Report results (Certificate of Origin, customer, or regulatory questionnaires) product assessments as part of product release or as requested by Project Management,
• Tech Service, Customers, Sales, Marketing and/or regulatory agencies.
• Inspection and final usage decision of critical raw materials used in production to specifications.
• Ensure these specifications are managed to latest regulatory and/or industry requirements in coordination with internal and external functions.
• Perform product specific projects to improve product quality performance, product quality information and/or improve customer satisfaction as requested by Project Management, Tech Service, Sales, and/or Marketing.

Physical Requirements:

• 70% - 90% Office Environment, 10% - 30% Production, QC, Packaging.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 2+ years of experience working in the life science industry.

OR

• Associate’s Degree and 5+ years working experience in a Quality Assurance role.

OR

• Bachelor’s Degree in any discipline and 5+ years working in a Quality Assurance role.

Preferred Qualifications:

• Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.
• Current fine chemical industry knowledge &/or experience desired.
• Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.)
• Good communication (verbal & written) and customer services skills.
• Good writing skills and experience writing procedures & report.
• Ability to simultaneously manage multiple tasks/priorities.
• Good problem-solving skills/abilities.
• Good time management and negotiating skills.
• Capacity for independent work.

RSREMD

Pay Range for this position: $27.00-$42.00 per hour.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!