Quality Assurance Specialist (St. Louis, Missouri, US, 63118-3306) bei None

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:

This individual 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. Duties in this role will include:

• Main job responsibilities will be review and approval of deviation, OOS and OOT investigations. 
• Administer daily and weekly deviation status meetings. 
• Maintain monthly deviations trending. 
• Write, review, and approve CAPAs and Change Controls.
• Participate in internal/external audits as needed.
• Provide quality oversight and support for new product introductions as primary quality point of contact.
• Respond to quality-related customer questions.
• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
• Review batch records for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
• Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
• Monitor for quality related issues and collaborate on resolution as quality on the floor.
• Lead Process Improvement for Quality related initiatives/projects.

Physical Attributes:

Environmental conditions will vary depending on specific job responsibilities; typically, 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) or other Life Science discipline
• 5+ years QA and/or QC experience.

 OR

• Master’s Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) or other Life Science discipline
• 2+ years QA and/or QC experience.

Preferred Qualifications:

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

RSREMD

Pay Range for this position: $65,800-$105,200.00

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!