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 individual will work various internal departments to improve and execute processes used in an ICH Q7 environment. Documentation control including: write, review or approve Operation Procedures, Specifications, Master Manufacturing Procedures and other QA-controlled documents. Ensure that all aspects of product (raw, intermediate, final) 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 verification of calculations, approval of MMFs, MPFs, generation of COA 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. This position will be 70-90% Office Environment, 10-30% Production, QC and Packaging.
Who you are:
B.S./B.A. in the Life Sciences, Chemistry, or Chemical Engineering with 1-2 years experience (i.e. GMP or API environment), B.S./B.A. in a non-science with at least 5 years applicable Quality System (i.e. GMP or API environment) experience in the specific QA job function as deemed appropriate by QA Management.
- Bachelor of Science or Art Degree in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering and 1+ years’ experience in a Quality Assurance environment
- Knowledge of ICHQ7 preferred
- Current API knowledge and/or experience desired
- Good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software required
- Excellent communication (verbal & written), excellent writing skills and experience writing technical documentation & reports required and customer interface skills required
- Ability to simultaneously manage multiple tasks/priorities required
- Good problem-solving skills/abilities required
- Good time management, negotiating skills required, and capacity for independent work required
- Data analysis, presentation, and experimental design knowledge desired
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.