Quality Specialist- 3Rd Shift

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, the QA Specialist will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7.

• Shift: Shift: Monday - Friday 11pm-7am.
• Participate in QA on the floor activities in manufacturing.
• Review batch records while in process during manufacturing events.
• Review batch records postproduction for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
• Review and approval of QC data to support batch disposition.
• Execution of batch and raw material disposition decisions.
• Provide quality oversight and support for new product introductions as primary quality point of contact.
• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols and other controlled documents under a Quality Managed System (QMS).
• Release activities for cGMP product and raw materials.
• Review and approval of master packaging formulas, master shipping records, and master manufacturing formulas.
• Document and label issuance activities.
• Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
• Monitor product for quality related issues and collaborate on resolution.
• Respond to quality-related customer questions, as needed.

Physical Attributes:

• Environmental conditions will vary depending on specific job responsibilities; typically, 10%-30% Office Environment, 70%-90% Production, QC, Packaging.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science discipline.
• 5+ years quality experience.

OR

• Master's Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science discipline.
• 2+ years quality experience.

Preferred Qualifications:

• Knowledge of ICHQ7 and API knowledge and/or experience.
• TrackWise and SAP experience.
• Proficiency in MS Word, MS Excel, MS PowerPoint and the ability to learn and operate other specific application software.
• Excellent communication (verbal & written) and customer interfacing skills.
• Experience writing technical documentation & reports.
• Ability to simultaneously manage multiple tasks/priorities.
• Good problem-solving, time management and negotiating skills.
• Capacity for independent work.
• Data analysis, presentation, and experimental design knowledge.

RSREMD

• Pay Range for this position: $62,500.00- $93,700.00.
• 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!