Quality Control Supervisor

3w3 weeks ago

Merck Group

Madison, US · Full-time · $80,700 – $121,100

About this role

At MilliporeSigma, the Quality Control Supervisor provides direct management and development of the department responsible for testing and timely release of in-process, intermediate, and final products. This role also oversees raw materials, method validation, and stability testing within a cGMP manufacturing environment, ensuring regulatory compliance and product integrity.

Leading a team to meet deadlines while preserving quality and safety, the supervisor applies analytical chemistry knowledge to lab procedures and troubleshooting. They are proficient with Chromeleon, SAP, LIMS, and scheduling tools to manage workflows. Typical hours are Friday through Sunday from 4:00 am to 4:30 pm, with flexibility between the Madison and Verona sites.

The supervisor coordinates with manufacturing, external labs, and project teams, supporting regulatory inspections and communicating progress effectively. Overseeing routine and non-routine QC testing, they compile technical reports and maintain accurate records and protocols. They manage change control processes for new and existing programs and drive continuous improvement through capacity planning, metrics tracking, and leadership in scheduling and planning activities.

This position offers the opportunity to lead a dedicated QC team and shape testing processes in a dynamic pharmaceutical environment. The supervisor plays a key role in developing technical training for QC personnel and ensuring strict adherence to cGMP and regulatory requirements. This role is crucial for maintaining high standards of quality and safety.

Requirements

Bachelor’s Degree in Chemistry, Biology, Biochemistry, or related life science discipline.
5+ years of experience in a cGMP analytical environment, or equivalent industry experience.
2+ years of 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 APIs.
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 and methodologies.

Responsibilities

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.
Proficient with Chromeleon, SAP, LIMS, FileMakerPro, and scheduling tools to manage workflows and data integrity.
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 and existing programs and 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.