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Supervisor, Quality Control
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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
At MilliporeSigma, the QC Supervisor will provide direct management and development of the In-Process Control/Intermediates and Finished Products Release team that is primarily responsible for testing and timely release of in-process, intermediate, final products. Other areas of responsibility may include, raw materials, method validation / qualification, and stability testing associated with cGMP manufacturing. Analysis performed within the QC Team involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
This position is responsible for leading the In-Process Control/Intermediates and Finished Products Release Team ensuring the execution of all the analyses is in compliant with regulatory requirements including oversight of the training program for QC personnel, support the maintenance and calibration of instrumentation, and all supportive efforts undertaken in the testing of cGMP materials under defined specifications. Direct management, engagement, and development of QC personnel are also primary responsibilities. Other responsibilities may include participation in process improvement initiatives, maintaining a clean and safe working environment, and supporting the department in maintaining the laboratory in an audit ready state. The position, like all positions at MiliporeSigma, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
ESSENTIAL JOB FUNCTIONS
· Provide leadership and organize team members to meet deadlines without compromising quality.
· Schedules and coordinates daily workload for laboratory analysts ensuring efficient use of resources to meet defined timelines.
· Demonstrate an understanding of analytical chemistry and laboratory procedures.
· Ensure appropriate technical training and coaching is provided for QC personnel.
· Perform routine and non-routine tests.
· Exercise judgment within defined procedures and practices to provide guidance and solutions for the Team.
· Provide guidance to the team when solving complex problems in which analysis of data requires an in-depth evaluation of various factors.
· Provide guidance to exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.
· Responsible for OOS/deviations investigations with the Team and ensure CAPAs are well defined, completed in time and executed.
· Demand and guide the team to apply critical thinking and good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with minimal assistance from Supervisor.
· Perform review of analytical data for accuracy and quality.
· Train and coach new or less experienced personnel in SOP content, analytical techniques, and instrument use.
· Meet with internal project groups to keep projects on track.
· Maintain projects and timelines for all responsible deliverables. Work collaboratively with internal and external clients to ensure all testing are in compliant to guidance and meting defined timeline.
· Support instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair as needed
· Schedule and coordinate daily workload for laboratory analysts ensuring efficient use of resources with minimum product turnaround times.
· Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7, 21 CFR Parts 11, 210, 211 and 820 (applicable sections) and ISO13485 as applicable
· Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
· Demonstrate proper laboratory safety and housekeeping practices.
· Use department resources efficiently and works within departmental budget.
· Identify areas for improvement and take action to undertake them through leadership and delegation to other members of the department.
Environmental conditions: Work near moving mechanical parts. Required to wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles as applicable. Must be willing to work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators.
Physical requirements: Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time. Occasionally lift and/or move up to 25 pounds unassisted and be capable of pushing
and pulling heavy materials to complete assignments. Lift more poundage with assistance. Vision specifications such as close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus. Regularly use phones, computers, computer monitors, and all office/laboratory equipment. Ability to ype at a computer keyboard and read CRTs/computer monitors.
Who you are:
· Bachelor’s Degree in Chemistry, Biology, Biochemistry, Chemical Engineering, or other life science discipline
· 3+ years of experience in an active pharmaceutical or cGMP production environment
· 2+ years management, supervisory, and/or lead experience
· Ability to act in a position of leadership and work in analytical testing labs with hazardous/toxic chemicals.
· Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for API’s
· Organizational, written, and verbal communication and interpersonal skills.
· Knowledge and understanding of organic analytical chemistry
· Adequate technical writing skills to author training memos and operating procedures
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!
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 Colorado or New York City, 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.