Quality Assurance Manager/GMP Expert at Millipore Corporation

Posted in Other 13 days ago.

Location: Miamisburg, Ohio





Job Description:

Work Location: Miamisburg, Ohio
Shift:
Department: LS-SC-PEMQ Quality Control
Recruiter: Michele Lee Stabinsky



This information is for internals only. Please do not share outside of the organization.




Your Role:



MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager/GMP Expert. As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies.


Responsibilities:


  • Lead a team that manages specific quality management systems and processes such as deviation, CAPA, change control, training, audits, complaint management, supplier quality, document control, validation, and data integrity

  • Ensure that departments responsible for products meet quality standards and performance goals of MilliporeSigma

  • Ensure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems

  • Support the site's compliance activities through accurate regulatory recordkeeping and reporting

  • Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMP

  • Drive risk reduction programs and ensure application of risk management and sound root cause analysis

  • Support the site's regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.




Who You Are:



Minimum Qualifications:

  • Bachelor's degree in Life Sciences, Pharmacy, Engineering, or other Science field

  • 5+ years experience with ISO 9001 and GMP requirements in a quality role inclusive of 2+ years experience in a leadership position

  • Experience in a chemical, specialty chemical and/or pharmaceutical industry




Preferred Qualifications:



  • 8+ years of experience with ISO 9001 and GMP requirements in a quality role in a chemical, specialty chemical and/or pharmaceutical industry

  • 3+ years of experience with increasing responsibilities as a people manager

  • Experience with quality management systems such as Trackwise, electronic document management system, etc.

  • Experience with customer audits and regulatory inspections



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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