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Quality Specialist 1
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 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.
The individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.
Responsibilities include but are not limited to:
- Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers and other quality records
- Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
- Review and approve validation files for systems and assays
- Review and approve deviation records; Conduct laboratory inspections
Who you are:
- Bachelor’s degree in scientific field (i.e. Biology, Biotechnology, etc.) or technical field (i.e. Engineering, etc.)
- 6+ months experience in Quality Assurance or related field within a GxP environment
- Acts ethically and ensures quality of own work and that of others
- Takes responsibility for ensuring that turnaround times are met
- Works with cross-functional teams and builds networks within QA and Operations departments
- Open-minded, flexible and works with agility
- Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
- Familiarity with International regulations (EMA, MHRA)
- Strong oral and written communication and interpersonal skills
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.