Quality Control Scientist

Merck•Madison, WI

1d•$70,000 - $112,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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