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Supervisor, Quality Control

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Merck KGaA

2021-12-03 14:59:04

Job location Verona, Wisconsin, United States

Job type: fulltime

Job industry: Science & Technology

Job description

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

Your role:

The Supervisor, Quality Control - Raw Materials at MilliporeSigma in Verona, WI will provide management of the Raw Material Quality Control department, which is primarily responsible for testing and timely release of raw materials. Other areas of responsibility may include, method validation/qualification, in-process, intermediate, final product, and stability testing associated with cGMP manufacturing. This position is responsible for supporting efforts to ensure the laboratory is compliant with regulatory requirements including oversight of the training program for QC personnel, maintenance and calibration of instrumentation, reference standard inventory program, and all supportive efforts undertaken in the testing of cGMP materials. Direct management, engagement, and development of Quality Control personnel are also primary responsibilities.

This position includes the oversight of analytical method transfers/qualification/validation into the QC laboratory, conducting analytical investigations, and testing using HPLC, GC, IC, GCMS, LCMSMS, KF, DSC, TGA, IR, NMR, Polarimetry, XRPD, UV-Vis, titration and other wet lab procedures. Additional responsibilities may include oversight and participation in change control, instrument calibration including IQ/OQ/PQ/PM and troubleshooting, cleaning verification/validation, stability studies, environmental monitoring, supplier qualification, and other projects as assigned.

* Demonstrates the ability to provide leadership and organize departmental staff to meet deadlines without compromising quality.
* Demonstrates an understanding of analytical chemistry and laboratory procedures.
* Ensures appropriate technical training is provided for QC personnel.
* May perform routine and non-routine tests as required. Operation of analytical instrumentation including those items specified above, with working knowledge of spectral and chromatographic interpretation and troubleshooting.
* Schedules and coordinates daily work load for laboratory analysts ensuring efficient use of resources with minimum product turnaround times.
* Works in accordance with current GMPs and regulatory requirements, and demonstrates proper laboratory safety and housekeeping practices.
* Uses department resources efficiently and works within departmental budget.
* Identifies areas for improvement and takes action to undertake them through leadership and delegation to other members of the department.
* Maintains accurate and concise records, including technical report writing.

Physical Attributes:

While performing the duties of the job, this employee may occasionally work near moving mechanical parts. May occasionally wear appropriate protective gear (hard hats, glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protection equipment "PPE" to protect themselves from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles. The work area may occasionally be wet, humid, or abnormally hot or cold. May involve lifting up to 50 pounds unassisted.

Who you are:

Minimum Qualifications:

* Bachelor's Degree in Chemistry, Chemical Engineering, or related Life Science.
* 5+ years of Quality Control experience in a GMP environment.

Preferred Qualifications:

* 1+ year of leadership experience in a life science manufacturing or quality control environment.
* Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7 Good Manufacturing Practice Guidance for APIs.
* Excellent organizational, communication (both oral and written), and interpersonal skills.
* Knowledge and understanding of organic analytical chemistry are preferred.

RSRMS Millipore Sigma MilliporeSigma

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits -

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If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 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.

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