Sr. Specialist, Quality Assurance

Company: Millipore Corporation
Location: Burlington
Posted on: April 11, 2021

Job Description:

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.Your Role:The scope of this leadership role is to lead, coordinate and execute the implementation and follow-up of the quality system for GLP compliance within the US End-to-End Laboratory which is dedicated to the process development of therapeutic biotechnology product. The responsibilities are leading, coordinating, and executing the followings (but not limited to) QA activities:

• Management of laboratory equipment qualification including Part 11 compliance; Audit of equipment for IQ/OQ
• Self-inspection in the laboratory and audit of external suppliers to guarantee respect of the quality requirements and continuous improvement
• Management of documentations including review and approval of key SOPs, plans and audit of raw data
• Qualification of raw material suppliers
• Review and approval of deviation, CAPA and changes with an objective of continuous improvement
• Being responsible as the QA representative in the customer projects
• Implementing and maintaining quality system with ensuring the alignment of QA activities with other two End-to-End sites and compliance to the Merck corporate quality system
• Lead and manage client and/or cooperate auditsWho You Are:Minimum Qualifications:
  • Master's Degree in Chemistry, Biology, Engineering or any other life science field AND 2+ years of experience in Quality Assurance within a GLP/GMP environmentOR
    • Bachelor's Degree in Chemistry, Biology, Engineering or any other life science field AND 4+ years of experience in Quality Assurance within a GLP/GMP environment Preferred Qualifications:
      • Working experience of Quality Assurance in a biological and/or cDMO organization
      • Experience of indirect management in matricula organization
      • Proficient to advanced knowledge of FDA regulations (GLP, Part 11)
      • Advanced working knowledge of good documentation practices
      • Strong Oral, written communication, and interpersonal skills
      • Capable of making quality related decisions and provide guidance in areas of expertiseWhat 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 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.

Keywords: Millipore Corporation, Boston , Sr. Specialist, Quality Assurance, Other , Burlington, Massachusetts