Lead QC Lab Supervisor – cGMP & FDA Regulated

PHIBRO ANIMAL HEALTH CORP; West Virginia; On-site; USD 90,000 - 130,000; Full time

Job summary

Phibro Animal Health Corporation in Willow Island, WV seeks an experienced QC Lab Supervisor to lead daily operations in an FDA-regulated manufacturing environment. You will oversee staff, analytical testing, data integrity, and system compliance to ensure accurate, timely results and regulatory adherence.

The role requires a Bachelor’s degree in a related field with substantial supervisory experience, strong knowledge of HPLC/GC/UV-VIS/FTIR, and a commitment to cGMP and continuous improvement.

Qualifications

• Bachelor’s degree or higher in a related science field and 7–10 years of scientific experience.
• At least 4 years in a regulated environment and preferably 2+ years in a supervisory role.
• Experience leading laboratory operations in an FDA-regulated setting.
• Familiarity with cGMP, FDA, and data-integrity practices.
• Strong analytical, communication, and problem-solving skills.

Responsibilities

• Plan and direct laboratory testing, studies, and projects supporting production, product release, stability, validation, and regulatory submissions.
• Set priorities, assign work, manage resources and timelines, and ensure effective use of personnel and equipment.
• Review data, reports, protocols, and product-disposition recommendations for scientific accuracy, completeness, and compliance.
• Provide basic HR support. Lead, coach, train, and evaluate laboratory personnel; maintain staff competency, development, and safe working practices.
• Provide technical oversight for laboratory methods and equipment, including HPLC, GC, UV/VIS, FTIR, balances, pH meters, titrations, sieves, and ovens.
• Ensure testing and documentation comply with FDA cGMP, GMP/GLP/GDP principles, SOPs, specifications, and data-integrity requirements.
• Maintain inspection readiness and oversee deviations, OOS or atypical results, nonconformances, CAPAs, and effectiveness checks.
• Oversee method validation, verification, transfer, lifecycle management, and continuous improvement.
• Ensure instruments are suitable, qualified, calibrated, maintained, and used in accordance with approved procedures.
• Evaluate SOPs, protocols, studies, and regulatory documentation with appropriate functions to support compliant, efficient operations and required changes.
• Support preparation and review of regulatory documents, including Annual Product Reviews, VMFs and NADAs.
• Communicate laboratory status, risks, findings, and recommendations clearly to management, staff, customers, vendors, and external partners.
• Prepare audit-ready technical reports and presentations, present data-based recommendations, and participate in internal and external audits.
• Monitor scientific, industry, and regulatory developments and implement appropriate changes.
• Partner with Manufacturing, Quality Assurance, Engineering, Product Development, Regulatory, Supply Chain, and external laboratories on product release, investigations, troubleshooting, method transfers, specifications, and projects.
• Enforce laboratory safety, chemical-handling, waste-management, and applicable aseptic practices; ensure hazards and incidents are promptly addressed.
• Support budgeting, workforce planning, performance reviews, personnel recommendations, and department goals.
• Anticipate operational issues, recommend solutions, and assume delegated manager responsibilities when needed.

Skills

Lead Analysts

Lab Management

Regulatory Compliance

Data Integrity

QC Methods

Education

Bachelor’s degree or higher in Chemistry, Biochemistry, Microbiology, Biotechnology, or a related field

Tools

HPLC

GC

UV/VIS

FTIR

LIMS

Empower CDS

Job description

Phibro Animal Health Corporation in Willow Island, WV seeks an experienced QC Lab Supervisor to lead daily operations in an FDA-regulated manufacturing environment. You will oversee staff, analytical testing, data integrity, and system compliance to ensure accurate, timely results and regulatory adherence.

The role requires a Bachelor’s degree in a related field with substantial supervisory experience, strong knowledge of HPLC/GC/UV-VIS/FTIR, and a commitment to cGMP and continuous improvement.