Quality Control Supervisor (HPLC, Raw Materials, Finished Products & Empower)

Job Summary

Develops, implements, and maintains quality control systems. Oversees inspection, testing, and evaluation of company products. Contributes to budget development. Recommends corrective actions to ensure product conformity. Ensures products meet government and company standards and comply with GMP regulations.

Essential Duties

• Provide general or direct supervision to exempt and skilled non-exempt employees.
• Act as an advisor to units or sub-units, becoming actively involved as needed to meet schedules or resolve problems.
• Enforce compliance with data integrity, SOPs, specifications, methods, USP, and cGMP through real-time verifications of records, logbooks, chromatograms, sequences, etc.
• Help analysts troubleshoot methods, instrumentation, and test execution.
• Schedule testing/review of raw materials, in-process, finished products, and stability samples, complaint samples, and samples from process and cleaning validation activities.
• Exercise judgment to determine appropriate action, critically review data for anomalies or trends, and approve data.
• Lead and approve investigations of suspect or out-of-specification results and ensure implementation of Corrective Action Plans (CAPA).
• May perform bench analysis, as needed.
• Frequently interact with subordinates, outside customers, and functional peers at various management levels, gaining cooperation and conducting presentations of technical information.
• Contribute to cross-functional projects with significant impact to the company.
• Observe and adhere to all Company, Health, Safety, and Environmental guidelines.

Minimum Qualifications

• BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training.
• Proficiency in MS Word, Excel, and PowerPoint.
• Strong interpersonal and organizational skills.
• Supervisory experience.
• HPLC proficiency.
• Experience with raw materials and finished products.
• Experience using Empower software.