Quality Control Supervisor

Merck•Madison, WI

5d•Hybrid

About The Position

At MilliporeSigma, the Quality Control Supervisor will provide direct management and development of the department that is primarily responsible for testing and timely release of in-process, intermediate, final products. Other areas of responsibility may include, raw materials, method validation / qualification, and stability testing associated with cGMP manufacturing. Typical hours: Friday, Saturday, Sunday 4:00 am – 4:30pm with flexibility of working between both Madison and Verona sites. Leads the team to meet deadlines while preserving quality and safety, optimizing workload and resource use. Applies analytical chemistry knowledge to lab procedures, spectral/chromatographic interpretation, and troubleshooting. Proficient with Chromeleon, SAP, LIMS, FileMakerPro, and scheduling tools to manage workflows and data integrity. Ensures technical training for QC personnel and strict adherence to cGMP, regulatory requirements, and housekeeping. Oversees routine and non-routine QC testing, compiles technical reports, and maintains accurate records and protocols. Manages change control processes for new/existing programs, and coordinates budgets for stability studies and final product release. Coordinates with manufacturing, external labs, and project teams; supports inspections and communicates progress effectively. Drives continuous improvement through capacity planning, metrics tracking, and leadership in scheduling and planning activities

Requirements

Bachelor’s Degree in Chemistry, Biology, Biochemistry, or related life science discipline
5+ years experience in cGMP analytical environment, or equivalent industry experience
2+ years management and/or supervisory experience
Ability to act in a position of leadership and work in analytical testing labs with hazardous/toxic chemicals
Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7A Good Manufacturing Practice Guidance for API’s
Excellent organizational, written, and verbal communication and interpersonal skills
Ability to work cross-functionally with teams that operate across various shift schedules
Ability to troubleshoot multiple systems/methodologies

Responsibilities

Provide direct management and development of the department responsible for testing and timely release of in-process, intermediate, and final products.
Manage raw materials, method validation/qualification, and stability testing associated with cGMP manufacturing.
Lead the team to meet deadlines while preserving quality and safety, optimizing workload and resource use.
Apply analytical chemistry knowledge to lab procedures, spectral/chromatographic interpretation, and troubleshooting.
Ensure technical training for QC personnel and strict adherence to cGMP, regulatory requirements, and housekeeping.
Oversee routine and non-routine QC testing, compile technical reports, and maintain accurate records and protocols.
Manage change control processes for new/existing programs.
Coordinate budgets for stability studies and final product release.
Coordinate with manufacturing, external labs, and project teams.
Support inspections and communicate progress effectively.
Drive continuous improvement through capacity planning, metrics tracking, and leadership in scheduling and planning activities.