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Quality Assurance Specialist
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.
This position is located at the Cherokee facility in St. Louis, MO. The Quality Assurance Department at this site supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice Guidelines (ICH Q7). This individual will work with various internal departments to improve and execute processes used in an ICHQ7 environment.
- Review Root Cause Analysis investigations and ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues.
- Documentation Control: write, review, and approve Operating Procedures, Specifications, Master Manufacturing Procedures, and other QA controlled documents
- Ensure that all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems
- Provide extensive review of manufacturing and quality control batch records, including verifications of calculations, approval of MMFs, MPFs, generation of Certificates of Analysis, and other release documents.
- Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
- Respond to quality-related customer questions.
Who You Are:
- Bachelor of Science or Arts Degree in Life Sciences, Chemistry, Pharmacy, Chemical, Process Engineering or related Life Science discipline
- 2+ years of experience working in an ICH Q7 cGMP environment
- Current API knowledge/experience
- Good computer skills
- Excellent written and verbal communication and customer interface skills
- Ability to multi-task
- Good problem-solving skills
- Good time management
- Experience with Environmental Monitoring
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.