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Quality Analyst II
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.
As a Quality Analyst II, you will support the daily operations of the Raw Material and Consumable Qualification Program activities which include project management of materials (consumables and raw materials) to be qualified for commercial cGMP manufacturing. Additionally, you will contribute to Chemistry and Biology teams’ efforts in qualifying those materials by performing some required analytical testing. The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed.
- Supports the daily operations of the Raw Material Qualification Program
- Support Raw Materials and Consumables qualification protocol generation, final report preparation, data summary and other related documentation as needed
- Manage collection, shipment, testing tracking of materials
- Responsible for performing a wide variety of analytical testing methods including raw material testing
- Operates and maintains lab equipment as required by SOPs and testing procedures requirements as well as perform analysis and interpretation of data
- Comply with company EH&S requirements
- Promote a safety-first culture
Who you are:
- Bachelor of Science in Biology, Chemistry or similar Life Science discipline with 2+ years of experience in Biotech, Medical Device, Pharma, Lab or other life sciences
- Bachelor of Arts in any general discipline with 3+ years of experience in Biotech, Medical Device, Pharma, Lab or other life sciences
- High School Diploma with 5+ years of experience in Biotech, Medical Device, Pharma, Lab or other life sciences
- Experience with cGMP, aseptic techniques, for machineries, equipment, software and data integrity
- Experience with project management, time management and task prioritization
- Understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals
- Experience in initiating, investigating, resolving and completing event records within our controlled quality system TRACKWISE.
- Experience ensuring testing compliance with ISO, FDA, cGMP, EMA and MilliporeSigma
- Knowledge of Aseptic Technique and Gowning
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.