Quality Assurance Supervisor, Audits (US Biologics)

Posted 07 Dec 2018

Rockville, Maryland - United States

Req Id 183717

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 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:

  • Assign and monitor the workload distribution to ensure audits are completed in a timely manner based on contractual obligations and mail dates.
  • Identify regulatory compliance issues and interact with other departments to ensure compliance with internal procedures and GXP regulations
  • Reviews quality records, documents, and event reports.
  • Conducts inspections, as need to support workload, for compliance requirements including highly custom and complex studies/productions.
  • Attend and/or lead cross-functional meetings/project teams as QA representative.
  • Ensure appropriate cross-training and professional development of staff.
  • Provides feedback, completes written performance reviews, documents any performances problems and takes appropriate action.
  • Trains and mentors other QA personnel in areas of expertise.
  • Supports client and regulatory inspections and may have direct interaction with clients and/or regulators.
  • Provides compliance /regulatory guidance to Operations for study / production planning purposes.
  • Normally receives no instructions on routine work and little to no instructions on new assignments.
  • Coordinate with other supervisor and group manager to maintain consistency of the team.

Who you are:

Minimum Qualifications:

  • B.S. degree in science or technical area.
  • 6+ years of experience in Quality Assurance or related field within a GXP environment.
  • Proficient to advanced knowledge of FDA regulations (cGMP, GLP, Part 11).

Preferred Qualifications:

  • Experience leading a project team or some supervisory experience is preferred.
  • Strong oral, written communication and interpersonal skills required.
  • Proven project team leadership skills.
  • Capable of making quality related decisions and provide guidance in areas of expertise.

 

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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

 

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