QC Supervisor - Raw Materials (RM)

COATING PLACE LLC•Verona, WI

About The Position

The QC Raw Material (RM) Supervisor supports the Formulations and Production Departments by scheduling analyses of pharmaceutical, nutraceutical, or industrial raw material samples delivered to the QC laboratory. The role ensures that samples are analyzed according to applicable internal procedures, specifications, analytical methods, compendia monographs, client procedures, and protocols. Testing primarily supports raw material evaluation and release. The supervisor is expected to understand internal procedures, establish good laboratory practices, and help chemists troubleshoot analyses and equipment. The QC RM Supervisor maintains a thorough understanding of USP, ICH, and FDA guidelines relevant to raw material and qualification activities and performs laboratory investigations, including quality and out-of-specification investigations, as needed. The position mentors, trains, and supervises the Raw Materials team, supports the Finished Product team as needed, and assists the QC FP/RM Manager with workload prioritization and reporting. The role also oversees testing, documentation, laboratory quality activities, and compliance with company cGMP and safety practices. This is a first-shift position, Monday through Friday, from 8:00 a.m. to 5:00 p.m. A $2,000 sign-on bonus is offered.

Requirements

Bachelor’s degree in Chemistry or a related field.
At least 3 years of supervisory experience in a cGMP pharmaceutical environment, or at least 3 years of experience at Coating Place, Inc.
Thorough understanding of USP, ICH, and FDA guidelines as they relate to qualification activities.
Demonstrated supervisory and leadership skills to train, direct, and motivate QC personnel.
Advanced time-management skills and ability to complete assignments and projects in a timely manner with minimal supervision.
Ability to establish and maintain effective working relationships with team members, coworkers, vendors, and clients.

Responsibilities

Mentor, train, and supervise the Raw Materials team; provide support to the Finished Product team as needed.
Assist the QC FP/RM Manager with workload prioritization and provide internal and external notifications and reports.
Coordinate analytical activities with direct reports, coworkers, clients, contract laboratories, and vendors, including quoting, testing, documentation, shipping, purchasing, and billing.
Compose, review, and approve SOPs, analytical methods, material specifications, deviations, and out-of-specification investigations.
Formulate, examine, and implement protocols and summary reports for routine stability studies, method validations, method transfers, and method verifications.
Perform and oversee testing involving dissolution, HPLC, GC, UV analysis, and wet chemistry procedures.
Assist Level 1–3 Chemists, Associate Scientists, Scientists, and Senior Scientists with tasks.
Maintain awareness of changing regulatory and industry requirements, including USP, FCC, EU, and JP requirements.
Generate and review QC metrics.
Perform final reviews of laboratory notebooks and equipment calibrations.
Participate in laboratory cleaning and maintenance activities.
Conduct annual performance reviews and meetings.
Follow Coating Place cGMP and safety practices, policies, and procedures.
Perform laboratory investigations, including quality and out-of-specification investigations, as necessary.
Other duties as assigned.