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Scientist, Quality (Method Validation)
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 Scientist, Quality position is responsible for the analytical method validation, qualification, and technical transfer of methods in the Quality Control department and all related cGMP paperwork. Analytical validation involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. This position may also be responsible for assisting with stability, raw material analysis and finished product testing as well as writing protocols, standard operating procedures, and technical reports. 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, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
- 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 techniques for obtaining solutions.
- Perform method validations/qualifications/transfers and write technical reports as needed.
- Able to solve problems and make decisions with limited assistance.
- Assist with development of testing methods to support cleaning verification programs, 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 and external project groups to keep projects on track.
- Maintain projects and timelines with minimal oversight.
- 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.
- Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from the supervisor.
- 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.
- Environmental Conditions: Work near moving mechanical parts. Frequently required to wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles. Must be willing to work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full-face respirators.
- Physical requirements: Regularly required to sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time. Must occasionally lift and/or move up to 25 pounds unassisted and be capable of pushing and pulling heavy materials to complete assignments. May be required to lift more poundage with assistance. Must be able to speak, hear, taste, and smell. Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus. Regularly use phones, computers, computer monitors, and all office/laboratory equipment. Required to type at a computer keyboard and can read CRTs/computer monitors.
Who You Are:
- Bachelors Degree in Chemistry, Biochemistry, Pharmacology or related science.
- 3+ years of experience in a GLP or cGMP analytical laboratory environment, or pharmaceutical 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 analytical chemistry and method validation.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.