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.
At MilliporeSigma, the Quality Control Scientist position is responsible for overseeing and leading out of specification investigations and non-conformance deviation investigations associated with release, stability and in-process 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 execution 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.
Who You Are: Basic Qualifications:
- 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.
- Bachelor's 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
- 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 non-conformance 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
RSRMSWhat 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.
Job Requisition ID: 213198
Location: St. Louis
Career Level: D - Professional (4-9 years)
Working time model: full-time
This job has expired.