St. Louis, Missouri, USA
17 days ago
Sr. Quality Assurance Associate

 

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:

In this role you will 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 established quality systems and regulatory/industry requirements.You will be the 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. Conduct 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.

Job Specific Competencies & Skills

Act as Auditor of Internal Auditing Program Conduct Training (individual, group)Batch review and usage decisionEnsure that aspects of a product’s quality requirements per MClarity™ Quality level are met including supply-chain traceability, vendor assessment, raw material inspection and release, change control and batch review in accordance with established policies and proceduresAssist in maintenance of ISO 9001 and ISO 13485 quality systems, in the areas of auditing (internal, supplier, and customer), training, cleaning, supplier qualification, environmental/water monitoring, complaint handling, and documentation/record controlAssist with customer related documents, including supply chain declaration/affidavits and Certificate of Origin creationEnsure acceptable product and process consistencyInteract with QA-QMS staff and other business functionsCapacity for independent workGood time management and negotiating skills

 

Physical Requirements:

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

Location: onsite St Louis, MO - 5 days per week in office

 

Who You Are:

Minimum Qualifications:

Bachelor’s degree in Life Sciences, examples: Chemistry, Pharmacy, Chemical or Process Engineering and 2+ years of experience working in the life science industry or Associate’s degree with 5+ years working experience in a Quality Assurance job or Bachelor’s degree in any discipline and 5+ years working in a Quality Assurance job

Preferred Qualifications:

Knowledge of other regulatory requirements (i.e., USDA, FDA, EC, DEFRA, ICH, and EDQM) Knowledge of SAP – Resource Planning (ERP) Business tool related to COA generation and release of products Knowledge of ISO 9001:2008 required, ISO 13485 Knowledge of animal/human pathogens desiredKnowledge of transgenic plant and animal desiredCurrent fine chemical industry knowledge &/or experience

 

 

 



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!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

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