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:

 

At MilliporeSigma, as the Quality Specialist 3 – 2nd shift, you will perform a variety of tasks within the Quality Assurance department including providing real-time Quality expertise on the floor, and ensuring GMP standards are met, verify compliance with standard operating procedures, conducting audits and review / approval of various types of regulated documentation and support integration of a Quality approach in all our processes. Solves problems of varying complexity independently by identifying and selecting solutions and by analyzing information. 

Shift – Monday-Friday 2:00pm-10:30pm Provide active Quality on the Floor (QotF) support to laboratory operations - by being present on the floor e.g. observing critical processes, performing visual inspection, scheduling/assay documents, and offering support in the flow of workReview and provide feedback on documents such as Laboratory batch Records, logbooks, and other GMP data/ records while being present on the floorLead and apply the highest standards of Data Integrity / Good Documentation Practices in our processes e.g. supporting document completeness, accuracy, and compliance (including online review of coordinated LIMS, and CofA generation or similar)Assist in timely resolution for quality-related issues and compliance concerns as a first responder If any issues or concerns arise, report them immediately to the Quality Assurance and/or Operations teamsPerform daily quality assessments/checks of classified/ non-classified areas to detect errors or deficiencies. Lead by example, always demonstrate a Quality approachContribute to self-inspection and process audits in laboratory operations and work closely with operations partners and GEMBA colleaguesReview and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality recordsReview 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 analysisReview and approve validation files for assaysWrite, review, and approve documents such as Standard Operating Procedures and Work InstructionsReview and approve deviations/OOS records of varying impact and criticality and approve change control (GCC) records Serve as liaison to Quality Culture initiatives and demonstrate Quality Culture in their daily workPrepare technical plans, reports, and protocols as neededPartner with other functions and departments e.g. project management, facilities, Inventory management, Test Article Receipt to alert them to Quality eventsAssist with quality improvement initiatives 

 

Who You Are 

 

Minimum Qualifications:

Bachelor Degree in scientific field (e.g., Biology, Chemistry, Biochemistry, etc.) 4+ years of experience in Quality field within a GxP environment

 

Preferred Qualifications:

2+ years in quality laboratory and/or experience as a manufacturing or laboratory floor inspector or technician in a fast-paced environment Acts ethically and ensures quality of own work and that of othersOpen-minded, flexible and works with agilityTakes responsibility for ensuring that turnaround times are metWorks with cross-functional teams and builds networks within QA and Operations departmentsCollaborates with various teams to identify and implement improvementsWilling to embrace and implement change on a global scaleExpert knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)Knowledge of laboratory operations, including equipment, materials, work flow, etc.Excellent communication, facilitation, and conflict resolution skills

$70,500 - $118,300

Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

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