Supervisor, Quality Control, GMP - Microbiology
Millipore Corporation

Job Info

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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:

You will be accountable for management of a GMP Quality Control Microbiology department supporting microbiological testing of APIs according ICH Q7 and 21CFR regulations; oversee the Quality Control activities associated with microbiological method validation/verification and transfer; testing of product; training on aseptic technique and test methods; OOS/OOT investigations; deviation and CAPA management. Specific job duties include:

• Your responsibility will include 2nd shift supervision,management and development of QC Microbiology team (5-8employees) and be accountable to meet business Quality performance metrics/ KPIs
  

• You will manage and prioritize microbiological method verification (Compendial)/ validation, Readiness for PPQ, Shift/test scheduling so products are released in a timely manner; track and manage a department budget and capital expenditure budget
  

• In this role you will develop and implement programs to establish and maintain quality systems, and quality standards of existing products and services, as well as developing programs to focus employees on quality improvements, developpolicies, procedures and methods to check and improve product, material, components, processes and/or operational quality
  

• Interface with internal and external customers on regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes
  

• You will perform other duties as required by your management
  

Who You Are



Minimum Qualifications:

• Bachelor's Degree in Biochemistry, Biology, or other Life Science Discipline
  

• 3+ years of experience as a quality control manager, supervisor, or lead in a regulated environment
  

Preferred Qualifications:

• Master's Degree in Biochemistry, Biology, or other Life Science Discipline
  

• Experience working in a highly matrixed organization
  

• Strong written and verbal communication skills, with the ability to translate complex issues into straightforward and succinct explanation
  

• Strong skills in root cause analysis and problem resolution
  

• Strong computer skills, including word processing, and Quality Systems databases
  

• Expertise in aseptic principles and practices
  

• Strong understanding of microbiological methodology and laboratory techniques, specifically USP< 85>; USP< 61> and USP< 62>
  

• Leadership and team building skills
  

• Knowledge of health authority FDA and EMEA expectations for pharma/biotech bulk and finished product manufacturing and microbiological testing requirements
  

• Knowledge of analytical instrumentation and software
  

• Knowledge of ICH Q7, 21CFR210, 211, USP and EP pharmacopeia requirements
  

RSREMD

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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