Quality Control Scientist
Quality Control Scientist
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1 Vacancy
Job Description
A career with MilliporeSigma is an ongoing journey of discovery: our 57000 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.
At MilliporeSigma the Quality Control Scientist position is responsible for overseeing and leading out of specification investigations and nonconformance deviation investigations associated with release stability and inprocess samples. The Quality Control Department at this site supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7.
The position is also responsible for and management of quality control CAPA projects and change controls. The QC Scientist must demonstrate strong technical knowledge be familiar with scientific/regulatory principles possess initiative and maintain a strong commitment to scientific excellence.
- Manage and lead Quality Control OOS and deviation investigations to adequately identify root cause and assign appropriate corrective and preventative actions (CAPAs) to prevent recurrence.
- Interact with the laboratory manufacturing quality assurance packaging and development personnel to ensure adequate root cause is identified.
- Work within various internal departments to improve and execute processes used in an ICHQ7 environment.
- Write review and approve operating procedures specifications and other QC controlled documents.
- Occasionally support and perform detailed data review for analytical data packets generated by quality control for compliance with cGMP internal SOPs and Specifications.
Who You Are:
Basic Qualifications:
- Bachelors degree in Chemistry Biochemistry Biology or related life science discipline
- 5 years of experience within a cGMP environment
- 1 years of experience working with ICH Q7
- Strong technical writing scientific reasoning and attention to detail
Preferred Qualifications:
- API manufacturing and testing knowledge and/or experience
- 5 years of work experience in pharmaceutical biopharmaceutical or similar industry
- Knowledge of 21CFR210 and ICH Q7.
- Experience using root cause analysis tools such as Fishbone 5Whys and pareto charts
- Experience in OOS/OOT investigations CAPA and nonconformance deviations
- Good computer skills including proficiency in MS Word MS Excel MS PowerPoint and the ability to learn and operate other specific application software
- Excellent written and verbal communication and customer interfacing skills
- Excellent writing skills and experience writing technical documentation and reports
RSRMS
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
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.
Employment Type
Full Time
