Manager, Quality Control

Manager, Quality Control

Millipore Sigma

Work your magic with us! Start your next chapter and join Millipore Sigma.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

As Quality Control Manager (Microbiology) you will be accountable for management of a GMP Quality Control Microbiology and Environmental Monitoring department supporting microbiological testing of APIs according ICH Q7 and 21

CFR regulations; oversee the Quality Control activities associated with microbiological method validation and transfer; testing of product;
Environmental monitoring; training on aseptic technique and test methods; OOS/OOT investigations; deviation and CAPA management.

• Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+ employees.
• Accountable to meet business and quality performance metrics through continuous process improvement initiatives.
• Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity.
• Detect quality problems within the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify هى to management.
• Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures.
• Attend project team meetings as the QC microbiology representative and work closely with the team to ensure on-time delivery.
• Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes.
• Develop and manage the department budget and capital expenditure budget. Interact with internal and external customers on regular basis.
• Participate and support regulatory/customer audits.
• Other duties as required.

• Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required. Master's degree in a scientific discipline or related discipline desired but not required.
• 10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience.
• Demonstrated experience working in a highly matrixed, GMP manufacturing setting.
• Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control;
  Clean rooms and Aseptic manufacturing;
  Environmental monitoring etc.
• Strong understanding of microbiological methodology and laboratory techniques, specifically USP.
• Knowledge of Laboratory Information Management System (LIMS).

• Preferred Qualifications
• Demonstrated leadership, Maisem development and team building skills.
• Solid track records in method development, method verification and validation.
• Strong written and verbal communication skills.
• Strong problem solving skills.
• Strong computer skills, including word processing, and Quality systems databases.
• Knowledge of GMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
• Knowledge of FDA practices and guidelines.
• Knowledge of pharma/biotech bulk and finished product manufacturing and microbiological testing requirements.
• Expertise in aseptic principles and practices.
• Knowledge of ICH Q7A, 21
  
  CFR, Eudralex GMP regulations, USP and EP pharmacopeia requirements.

Pay Range for this position: $134,400-$201,600. The offer range represents the anticipated low and high end of theologue pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education=?skills& 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 .

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. 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.