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A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
The QC Scientist, In Process and Final Release position at MilliporeSigma is responsible for the routine analysis of samples in the Quality Control department and all related cGMP paperwork. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. This position will assist with method qualification/validation, writing protocols and standard operating procedures. Other responsibilities include participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state. The Scientist, Quality position, like all positions at SAFC, contribute to the overall success of the company by assisting in many areas beyond specific job duties.
Job responsibilities will include but not be limited to:
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Exercise judgment within generally defined procedures and practices to select technique for obtaining solutions.
- Able to solve problems and make decisions with assistance.
- Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program as needed.
- Assist with development of testing methods to support cleaning verification program, validate or verify methods, and perform cleaning verification as needed.
- Perform preliminary review of analytical data for accuracy and quality.
- Help train new or less experienced personnel on procedures, analytical techniques, and methodologies.
- Meet with internal project groups to keep projects on track.
- Maintain projects and timelines with minimal oversight.
- Perform method validations/qualifications/transfers and write technical reports as needed.
- Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair as needed.
- Demonstrate proper laboratory techniques during analytical testing for raw materials, in-process, final products, intermediates, and stability samples. Recognize problems with analytical test results or method performance and take appropriate steps to address them. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
- Participate in OOS and OOT investigations via testing and good documentation.
- Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
- Perform requalification of reference standards and maintain reference standard inventory/documentation.
- Write and revise SOPs including raw material, intermediate, and final product specifications.
- Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
- Work cooperatively within the QC department and with other departments to achieve project goals.
- Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
- Work in a safe manner and maintain the cleanliness of the work environment.
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
- Regularly Sit, Stand, walk, reach above the shoulder, stoop, kneel, twist, crouch or crawl for at least 50% of the time.
- Wearing protective gear (lab coats, safety glasses/goggles) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.
- Working with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators.
- Lifting and/or moving up to 25 pounds unassisted and pushing and pulling heavy materials to complete assignments. Lifting more poundage with assistance.
- Speaking, hearing, tasting, and smelling
- Specific vision attributes include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus
- typing at a computer keyboard and can read CRTs/computer monitors.
Who You Are
- Bachelors Degree in Chemistry, BioChemistry or related biological sciences
- 5+ years in a cGMP analytical laboratory environment, or equivalent industry experience
- Understanding of 21 CFR Part 11, 210 and 211 and ICH Q7
- 5-8+ years in a cGMP analytical laboratory environment, or equivalent industry experience Excellent written and verbal communication skills, as well as excellent documentation practices
- Ability to work in analytical testing labs with hazardous and toxic chemicals
- Knowledge and understanding of organic analytical chemistry
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.