Quality Operations Supervisor

Posted 21 Aug 2019

Rocklin, California - United States

Req Id 196611

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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:

 

Responsible for providing Quality Operations leadership for the Rocklin site, focusing on the overall Quality release of products.

 

This role will be responsible for the direct supervision of the Quality Operations team according to established policies and under management guidance. Plan, organize, and supervise activities for the Quality Operations Department and supports the overall Quality organization at the Rocklin site and as directed, within the Life Science organization.

As part of the management team that reports to the Rocklin Site Quality Manager, you would ensure compliance of the QMS in accordance with but not limited to the following standards and regulations - ISO134845: 2016, FDA QSR, IVDD/IVDR, CMDR, ANVISA, TGA. Develop and implement programs to maintain quality standards of products as directed from the site Quality Objectives and initiatives. Review, monitor, and ensure that all deviation, CAPA, MRB and risk assessments are completed and timely per local and global requirements. This role will also provide quality leadership and direction to support business operations. Responsible for ensuring that quality processing of materials meets established timelines and ensures that nonconforming materials are appropriately dispositioned.

 

Additional responsibilities include but are not limited to interviewing, hiring and training employees, resource planning, assigning and directing work, appraising performance and disciplining employees, responsible for reporting metrics related to quality processing of materials including but not limited to throughput, deviation, and MRB, write, revise and/or review quality system documentation while adhering to regulatory requirements. You may be required to work on various projects to improve efficiency and/or compliance.

 

This role will require you to be detail oriented and results driven with ability to concisely communicate verbally and written as well as be competent in Microsoft Word, Outlook, and Excel as this role directly support the QC, QA, and QE departments and internal and/or external audits.

 

Who You Are:

 

Basic Qualifications:

 

  • An undergraduate degree in biological science or equivalent life sciences degree is required.
  • 5+ years’ experience in a regulated environment such as FDA or ISO-13485
  • 2+ years Supervisory experience in leading a team

 

Preferred Qualifications:

 

  • Working knowledge of SAP/SAP NEXT, Oracle or Trackwise highly preferred
  • Knowledge and experience in IHC, ELISA, and Bioburden testing is preferred

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!

Curious? Apply and find more information at https://jobs.vibrantm.com


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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