Raw Materials QC Lead – cGMP Lab

Actalent; Verona (WI); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Sign-on bonus

PTO accrual up to 17 days

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Disability insurance

401(k) with 5% match

Tuition reimbursement

Job summary

Actalent is seeking a QC Supervisor for Raw Materials in Verona, WI to lead a six-chemist team and ensure on‑time testing and release of pharmaceutical, nutraceutical, and industrial materials. The role demands cGMP expertise, hands-on HPLC/GC, and strong collaboration with Production and external clients.

The position offers a robust benefits package and a pathway for professional growth within a modern QC laboratory environment.

Qualifications

• B.S. degree in chemistry, biochemistry, biology, or a related life science field.
• At least 3 years of cGMP experience in a laboratory or quality control environment.
• Strong knowledge of USP, with experience in USP and EP raw material testing highly preferred.
• Hands-on experience with HPLC and GC in an analytical chemistry or quality control setting.
• Proficiency in wet chemistry techniques, including titration and related methods.
• Demonstrated leadership experience, either through direct supervision of staff or strong project/team leadership.
• Quality control and QC testing experience with raw materials in a regulated environment.
• Ability to prioritize effectively, take ownership of responsibilities, and operate with a sense of urgency.
• Experience working within systems such as Empower, LIMS, and/or MasterControl.
• Strong verbal and written communication skills, with the ability to work collaboratively with clients and cross-functional teams.
• Ability to troubleshoot analytical methods and laboratory equipment and provide technical guidance to team members.
• Solid understanding of cGMP, safety, and quality procedures in a laboratory setting.

Responsibilities

• Lead, mentor, train, and supervise the Raw Materials QC team while providing support to the Finished Product QC team as needed.
• Prioritize and coordinate raw material testing and release activities to ensure materials are available to meet Production and Formulations schedules.
• Manage a fast-paced workload with multiple priorities, frequent interruptions, and evolving testing needs, while maintaining high quality standards.
• Work closely with Production and Formulations teams to communicate testing status, priorities, issues, and raw material release timelines.
• Oversee testing and analysis of pharmaceutical, nutraceutical, and industrial raw materials according to USP, EP, internal specifications, analytical methods, compendial monographs, and client requirements.
• Maintain strong working knowledge of USP and EP raw material requirements and stay current with applicable regulatory and compendial standards, including ICH, FDA, FCC, EU, and JP requirements.
• Lead raw material investigations, including deviations, quality investigations, and Out-of-Specification (OOS) results, ensuring thorough root cause analysis and appropriate corrective actions.
• Partner closely with Quality and external clients during investigations, providing clear updates and effectively communicating technical findings.
• Review and approve SOPs, analytical methods, material specifications, deviations, OOS investigations, protocols, and summary reports for accuracy and compliance.
• Oversee and troubleshoot laboratory testing using HPLC, GC, UV, titration, and other wet chemistry techniques.
• Provide technical guidance and troubleshooting support to Chemists and Scientists on analytical methods, testing issues, and laboratory equipment.
• Support method validations, method transfers, method verifications, and routine stability studies for raw materials.
• Perform and oversee analytical data review to ensure that testing and documentation meet established procedures, cGMP expectations, and quality requirements.
• Coordinate activities with internal teams, clients, contract laboratories, and vendors related to testing, documentation, shipping, purchasing, quoting, and billing.
• Generate and review QC metrics and provide regular workload and testing updates to leadership.
• Promote strong laboratory practices and ensure compliance with applicable cGMP, safety, and quality procedures at all times.
• Conduct annual performance reviews and hold regular meetings with direct reports to provide feedback, coaching, and development opportunities.

Skills

B.S. degree in chemistry

cGMP experience

USP knowledge

HPLC

GC

wet chemistry', titration

leadership experience

QC testing experience with raw materi

Empower/LIMS/MasterControl

communication skills

troubleshooting analytical methods

cGMP safety and quality procedures

Education

B.S. degree in chemistry, biochemistry, biology, or a related life science field

Tools

Empower

LIMS

MasterControl

Job description

Actalent is seeking a QC Supervisor for Raw Materials in Verona, WI to lead a six-chemist team and ensure on‑time testing and release of pharmaceutical, nutraceutical, and industrial materials. The role demands cGMP expertise, hands-on HPLC/GC, and strong collaboration with Production and external clients.

The position offers a robust benefits package and a pathway for professional growth within a modern QC laboratory environment.