SUMMARY:The Quality Lead is responsible for 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.
Work Schedule: Monday - Friday 8am-5pmJOB QUALIFICATIONS:- 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, including the ability to maintain secure, accurate, compliant, and inspection-ready records.
POSITION RESPONSIBILITIES:- 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, including the ability to maintain secure, accurate, compliant, and inspection-ready records.
PHYSICAL REQUIREMENTS:- Work safely and follow all OSHA regulations and company safety policies and procedures.
- Works frequently in a lab environment, handling of chemicals.
- Employees are 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:PLD is a proud equal opportunity employer offering many corporate benefits, including:
- 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 to Flourish Within the Company
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