Quality Manager
MilliporeSigma

Job Info

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A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

As the QA/QC Manager, you will lead all aspects of the site QA/QC activities associated with product testing (finished product, intermediates, in process samples and raw materials), lab equipment, LIMS systems, sample retention, and QA/QC documentation and will be solely responsible for all quality staff which conduct these quality control and quality assurance activities within a high volume/high complexity site.

You will be accountable for management of the site ISO9001 Quality Management System, Document Control System, Training Compliance, and Quality Control Department supporting the solvent and solutions manufacturing and distribution center.

The 24/5 QC operations group consists of 1 QC supervisor and a total of approx. 7 employees. The QA group consists of 1 QA supervisor and 2 employees. This is a great opportunity to lead a dedicated team!

Responsibilities:

• Ensure that all materials and products that require testing and release in the laboratory are done so according to agreed specifications and procedures.
• Liaise with planning and project teams (internal and external) to support the site production schedule.
• Responsible for the safety of the quality control lab areas and QA staff operations.
• Develop and implement QA/QC policies and procedures.
• Ensure all QA/QC work is completed in timely manner and up to date.
• Ensures lab and quality documentation and computerized systems comply with data integrity policies and regulatory requirements. The QA/QC Manager will prepare, review, and approve documents as needed.
• Understands Regulations and business processes required to maintain Lab and Quality Data Integrity; Represents QA/QC matters during regulatory agency and customer inspections.
• Manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all QC samples.
• Leads the QA/QC workstream of technology transfer as part of the LS ISCO business assuring the milestones of the projects are reached.
• Manage the investigation into any customer complaint, internal complaint, non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are captured as per standard operating procedures (SOP).
• Responsible for monitoring, statistically analyzing, trending and reporting of QA/QC data/metrics to evaluate performance and risks
• Effectively engages in continuous improvement teams to implement and maintain a system for capacity planning and demand forecasts for QA/QC department.
• Compiles data and develop analysis to support QA/QC investigations, KPIs and other QA/QC reporting as requested.
• Develop and manage the department budget and capital expenditure budget for QC lab and equipment.
• Lead and coach team members in achieving corporate, site, and department goals and objectives.

Who you are:

Minimum Qualifications:

• Bachelor's degree in Chemistry, Chemistry Engineering, Pharmacy, Biochemistry, Biology or a related science.
• Minimum 8 years' of applicable experience in quality control / quality assurance operations
• Experience leading a team of direct reports
• Knowledge of ISO9001 QMS.
• Knowledge of ACS Lab specifications.

Preferred Qualifications:

• Pharmaceutical or Chemical manufacturing quality control operations experience
• Proficient knowledge of and ability to use Microsoft Word, Excel and Access.
• Excellent interpersonal, written, and verbal communication skills
• Results driven, team player, able to balance multiple projects/tasks

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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
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

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

As an employee of the Company, you will be required to comply with all of the Company's COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

Job Requisition ID: 250150

Location: Norwood

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.