Quality Control Scientist

Work Location: Madison, Wisconsin
Shift:
Department: LS-SC-UYWQEB QC Project Readiness Team 2
Hiring Manager: Shawn Kotecki

This information is for internals only. Please do not share outside of the organization.

Your Role:

MilliporeSigma is seeking a skilled and motivated Analytical Chemist with expertise in validation of methods for cleaning of GMP manufacturing equipment and validation of analytical methods to support a multidisciplinary CDMO center in Madison/Verona WI. The successful candidate will be responsible for conducting advanced chemical analyses, developing, transferring, and validating analytical methods to support cleaning and general analytical methods, and ensuring the accuracy and reliability of test results. The Quality Scientist position, like all positions at SAFC, will have a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

• Develop, optimize, and validate analytical methods for cleaning of GMP manufacturing equipment while maintaining accurate documentation of procedures
• Work on complex problems in which analysis of data requires an in-depth evaluation of various factors
• Perform analytical testing of cGMP materials, guaranteeing data accuracy and quality through proper laboratory techniques while managing tight project deadlines
• Maintain and troubleshoot instruments, conducting performance verifications and operational qualifications as needed
• Collaborate with cross-functional teams on research and development projects, providing technical support and training to junior staff
• Document and investigate out-of-specification (OOS) and out-of-trend (OOT) results, applying critical thinking to identify root causes and corrective actions
• Ensure laboratory safety and cleanliness, managing supplies and housekeeping tasks to maintain an audit-ready environment
• Author and revise standard operating procedures (SOPs) in compliance with regulatory requirements, supporting data integrity initiatives

Physical Attributes:

• Work in analytical testing lab with hazardous and toxic chemicals
• Bend, stoop, squat, crawl, kneel, climb, or reach overhead
• Wear required PPE such as safety glasses, gloves, masks, and steel-toed shoes

Who You Are

Minimum Qualifications:

• Bachelor’s Degree in Chemistry, Biology, or other Life Sciences discipline.
• 5+ years experience in a cGMP analytical laboratory environment

Preferred Qualifications:

• Thorough understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
• Understanding of validation of cleaning methods for an active pharmaceutical ingredient plant
• Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail
• Knowledge and understanding of analytical chemistry
• Adequate technical writing skills to author reports and operating procedures
• Strong team player and willing to adapt to changes / be flexible
• Proven problem-solving skills and attention to detail

Pay Range for this position:$70,000-$112,000.

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 clickhere.

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.