Quality Lead

About the role

Leading Quality Control laboratory operations and ensuring analytical testing, stability programs, laboratory documentation, and equipment activities are performed in compliance with cGMP requirements and company procedures. This role provides technical leadership, supports laboratory investigations, maintains audit readiness, and collaborates with cross-functional teams to ensure product quality, regulatory compliance, and continuous improvement of laboratory operations.

Responsibilities

• Lead Quality Control laboratory operations in compliance with cGMP requirements and company procedures.
• Provide technical leadership and support for laboratory investigations.
• Maintain audit readiness for laboratory operations.
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance.
• Oversee analytical testing, stability programs, and laboratory documentation.
• Manage stability study set-up, sample management, protocol execution, sample pull scheduling, data review, and issuance of stability-related documentation and summary reports.
• Ensure adherence to good documentation practices, data integrity principles, and laboratory investigation processes.
• Coordinate calibration systems, preventive maintenance, and troubleshooting of routine laboratory equipment.
• Manage deviation, OOS/OOT processes, and CAPA systems.
• Maintain secure, accurate, compliant, and inspection-ready records using laboratory software systems and Microsoft Office.

Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline, or an equivalent combination of education and relevant experience.
• Minimum of 5–10 years of progressive analytical laboratory experience in a pharmaceutical, OTC, medical device, or other regulated cGMP environment, with demonstrated responsibility in quality control and laboratory operations.
• Minimum of 3-5 years of experience in leadership roles and technical experience is preferred.
• Strong technical knowledge of analytical testing, stability program support, laboratory instrumentation, calibration systems, preventive maintenance coordination, and troubleshooting of routine laboratory equipment.
• Demonstrated experience with stability study set-up, sample management, protocol execution, sample pull scheduling, data review, and issuance of stability-related documentation and summary reports.
• Working knowledge of cGMP requirements, good documentation practices, data integrity principles, laboratory investigations, deviation management, OOS/OOT processes, CAPA systems, and audit readiness expectations applicable to pharmaceutical laboratories.
• Strong analytical, investigative, and organizational skills, with the ability to prioritize multiple activities, manage timelines, and perform effectively with minimal supervision.
• Excellent interpersonal, written, and verbal communication skills, with the ability to collaborate across Quality Control, Quality Assurance, Operations, external laboratories, and service providers.
• Proficient in Microsoft Office and laboratory software systems.

Physical Requirements

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• Frequent work in a lab environment, including handling of chemicals.
• Required to wear eye protection and lab coats while in the lab area.
• Ability to frequently lift and/or move up to 25 lbs.
• Ability to occasionally lift and/or move up to 35 lbs.
• Ability to regularly stand, sit, and walk to perform tasks.

Benefits

• Medical and Dental Benefits
• Vision
• 401K with employer match
• Group Life Insurance
• Flex Spending Accounts
• Paid Time Off and Paid Holidays
• Tuition Assistance
• Corporate Discount Program
• Opportunities for career growth within the company

Schedule

Monday - Friday, 8am-5pm