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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Scientist, Quality position is responsible for validating methods and technical transfers as well as providing technical and analytical leadership to the Quality Control department at Millipore Sigma. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. The position demonstrates the ability to work on, and solve, problems independently with some guidance. Other responsibilities may include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s. Additionally, participation in process improvement initiatives, and working in a team environment. In this role, you will contribute to the overall success of the company by assisting in many areas beyond specific job duties.
Perform method validations, transfers and analytical testing of cGMP materials; ensure data accuracy with proper techniques and documentation.
Conduct and contribute to peer review of analytical data (e.g., HPLC, KF, GC) to ensure quality.
Train new or less experienced personnel on SOPs, analytical methods, and instrument operation.
Maintain a safe, audit-ready, and clean lab environment with rigorous data integrity.
Manage lab upkeep: order reagents, ensure clean glassware, dispose of waste properly, and perform general housekeeping.
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Tackle complex data-analysis problems; apply critical thinking and lead root-cause analysis in OOS/OOT investigations with corrective/preventive actions.
Perform instrument PVs and OQs; coordinate with internal and external groups to keep projects on track.
Author and revise SOPs and specifications (raw materials to stability); ensure compliance with ICH Q7 and 21 CFR Parts 11/210/211; support right-first-time data integrity.
Physical Attributes:
Wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant suits, 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.
Work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators, Saranex and/or Tyvek suits with powered respiration.
Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.
Occasionally lift and/or move up to 30 pounds unassisted, push/pull heavy materials to complete assignments, and lift more poundage with assistance
Speak, hear, taste, and smell.
Use close vision, distance vision, color vision, peripheral vision, depth vision and adjust focus.
Minimum Qualifications:
Bachelor’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline.
5+ years of experience in a GLP or cGMP analytical laboratory environment.
Preferred Qualifications:
Experience with method validation.
Experience as a project lead.
Experience with team and client interactions.
Experience with technical writing skills to author operating procedures, protocols and reports.
Knowledge and understanding of organic analytical chemistry.
Pay Range for this position: $63,600-$95,500.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here
RSREMD
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.
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