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Millipore Sigma

Specialist, Quality Assurance

Post Date:Apr 16, 2018Type:Full-Time
Start Date:4/16/2018Salary:
Location:US-WI-Madison Job Reference:173829
Skills:
 



Job Description:

A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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

Ensure that all aspects of product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems. Support the maintenance, development and improvement of GMP quality systems, such as auditing (internal, supplier, and customer), training, process validation, cleaning validation, change control, complaint handling, and documentation control.


ESSENTIAL JOB FUNCTIONS

•    Review and approve executed GMP batch documentation
•    Generate, review, and apply product labels
•    Write and route operating procedures, manufacturing documents, and other QA controlled documents in QUMAS
•    Interact with internal customers
•    Support quality systems
•    Issue logbooks 
•    Issue/review controlled forms
•    Scan executed batch records and maintain electronic files for future reference as necessary
•    File executed quality documentation in the records room
•    Enter data into multiple systems to ensure compliance with regulations
•    Support SAP for the quality unit
•    Perform walk-throughs, changeovers, and QA on the floor inspections
•    Provide project support for QA
•    Serve as customer proxy for projects as assigned
•    Create and revise job aides
•    Support the management of change program for all product quality-related changes to documents, specifications, and methods
•    Review and approve master document revisions in QUMAS
•    Respond to quality-related customer questions
•    Present various GMP quality system training topics to production, laboratory, and quality personnel, if needed
•    Support customer complaint investigations pertaining to quality and process related issues, if needed
•    Participate in government regulatory audits as needed


ADDITIONAL JOB FUNCTIONS (as assigned)

•    Serve as MRB coordinator
•    Serve as QA resource for cleaning verification/validation
•    Review and approve validation/quality reports
•    Support process development including attending project meetings and review and approval of new master documents in QUMAS


Who You Are

  • Education: Bachelor’s degree in Life Sciences, Chemistry, or Chemical Engineering with 3-5 years experience in a GMP or API environment, Bachelor’s degree in a non-science with at least 10 years experience in a GMP or API environment, or a Master’s degree in Life Sciences, Chemistry, or Chemical Engineering with 2-4 years experience in a GMP or API environment.   
  • Knowledge and skills - 
  • General understanding of Q7 (current) Good Manufacturing Practices
  • Good computer skills, including proficiency MS Word, MS Excel, MS Access
  • Good time management skills
  • Excellent interpersonal skills for interacting with many internal departments
  • Ability to organize and prioritize tasks effectively
  • Capacity for independent work
  • Advanced written skills for technical protocols and reports, as well as customer response letters
  • Excellent problem-solving skills for out-of-specification and process deviation investigations

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.





Contact Information
Millipore Sigma



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