Senior Associate Quality Control Scientist

Merck•Madison, WI

5d•Onsite

About The Position

MilliporeSigma is seeking a skilled and motivated Analytical Chemist with HPLC experience for analysis of cleaning samples taken from GMP manufacturing equipment and to support a multidisciplinary CDMO center in Madison/Verona WI. The successful candidate will be responsible for performing analytical testing, collecting samples from GMP manufacturing equipment, and reporting of analyzed data. The Quality Associate Senior 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
3+ years experience in a cGMP analytical laboratory environment
Thorough understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
Experience with HPLC/UPLC Analytical Techniques
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

Nice To Haves

preferred experience with LC/MS-MS instrumentation

Responsibilities

Perform analytical testing of cGMP materials (cleaning samples from GMP Manufacturing equipment) and ensure accuracy and quality of data by using proper laboratory techniques and documentation
Coordinate with Manufacturing Department for the collection of samples of GMP Manufacturing equipment
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
Work cooperatively within the QC department and with other departments to achieve project goals.
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