QC Supervisor (2nd Shift)

About the role

The QC Supervisor is responsible for managing a Quality Control (QC) team, ensuring staff development, timely support for manufacturing, safety and GMP compliance. Provide technical and compliance guidance to ensure the safety and productivity of the group. Oversee QC projects, ensuring on-time completion with a high degree of Quality. Provides leadership to the group through effective communication, coaching, training, development. Ensure staff acts in accordance with company policies and other applicable regulatory requirements (e.g. GMP, ICH, OSHA).

Responsibilities

• Oversee and direct the work of Quality Control Chemists who perform GMP testing of raw materials, intermediates, and APIs in support of pharmaceutical manufacturing.
• Interact with Production teams to assess Quality Control support needs and coordinates coverage for all shifts on assigned team.
• Supervise QC personnel (including hiring decisions, evaluations of performance, and identification of training and development needs).
• May be required to perform analysis and report results in accordance with cGMP & GLP requirements.
• Owns and participates in Deviation and OOS investigations, and pushes them toward closure.
• Develops, improves, and revises SOPs, test methods, and other GMP documentation.
• Led the transfer of analytical procedures from the Analytical Development group as well as directly from the client sites.
• Identifies and leads continuous improvement initiatives.
• Communicate with internal and external clients.
• Actively participates in quality and safety audits and walkthroughs.
• Performs work following all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

Qualifications

• BS in Chemistry, or equivalent, with 5+ years related experience -OR- MS in Organic Chemistry or equivalent with 3+ years related experience.
• Experience with common analytical techniques such as HPLC/UPLC, GC, NMR, UV-Vis, pH meter, KF, FTIR, and Refractive index.
• 3+ years’ experience using chromatography (GC, HPLC/UPLC).
• 2+ years' experience with Quality records (e.g. deviations, CAPA, OOS).
• 3+ years’ previous GMP experience.
• Experience training other chemists on test methods and QC operations.
• Previous experience leading other chemists in a GMP environment preferred.
• Experience with Empower chromatographic software preferred.

Pay

The salary range for this role is $100,000-$110,000. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Moderate PTO and holiday pay policies.
• Fair and transparent compensation practices.
• Competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match.
• Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture.