Sr. QC Laboratory Manager

Safetec of America • Buffalo, NY

2d

About The Position

Safetec of America, Inc. is a local, family-owned OTC pharmaceutical manufacturing company and a provider of infection control, first aid, and compliance products. The Sr. QC Laboratory Manager leads the Quality Control laboratory and its quality systems, testing programs, team, and continuous-improvement efforts. The role ensures laboratory activities and product reviews comply with applicable internal procedures and regulatory requirements.

Requirements

• Bachelor’s degree in chemistry, microbiology, or another related scientific field.
• At least 8 years of experience in a Quality Control laboratory environment.
• At least 6 years of leadership experience.
• Strong knowledge of analytical chemistry, laboratory testing methods, method validation, stability programs, laboratory instrumentation, and troubleshooting.
• Thorough understanding of FDA regulations, cGMPs, USP requirements, GLP principles, and applicable quality standards.
• Experience managing laboratory quality systems, investigations, deviations, CAPAs, change controls, and data integrity requirements.
• Demonstrated ability to lead, develop, and mentor technical personnel, manage departmental priorities, and drive accountability.
• Strong problem-solving, statistical analysis, data interpretation, and decision-making skills.
• Excellent written and verbal communication skills and ability to collaborate across Quality Assurance, Manufacturing, Regulatory, and other departments.
• Ability to manage multiple priorities, projects, and deadlines while maintaining accuracy and attention to detail.

Nice To Haves

• Experience in OTC pharmaceutical manufacturing or a regulated manufacturing environment.

Responsibilities

• Develop, implement, and monitor Quality Control programs, SOPs, and key performance metrics aligned with internal procedures and regulatory requirements.
• Oversee raw material, in-process, finished goods, and stability testing, ensuring analytical methods are validated and qualified.
• Ensure reviews and approvals of raw materials and components, stability studies, and finished goods are performed in accordance with cGMP and GLP requirements.
• Lead and mentor QC staff, manage schedules and performance, and support skill development.
• Facilitate cross-functional communication and ensure testing, metrics, projects, and departmental goals are achieved.
• Ensure regulatory compliance and lead internal and external audits, root-cause investigations, and corrective and preventive actions.
• Support laboratory investigations and ensure corrective and preventive actions are implemented for OOS/OOT investigations, customer complaints, and QC activities, as appropriate.
• Drive quality initiatives, lean processes, and process optimization.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior