Job Description

Quality Control Lab Manager

Job Description:

The Quality Control (QC) Lab Manager is responsible for ensuring the smooth operation of QC laboratory activities, delivering consistent product quality and efficiency. This role oversees method development, validation, and method transfer, as well as the testing of materials (including in-process, raw materials, stability, and finished goods). The QC Manager will drive continuous improvement, ensure regulatory compliance, and maintain Tri-Pac’s Quality Management System. Key duties include reviewing and approving protocols, reports, deviations, investigations, and all QC-related documentation. The QC Manager will also coordinate communication between management, production, and other operational teams.

Responsibilities:

• Team Leadership & Development: Coach and develop a self-sufficient lab team, ensuring knowledge transfer and seamless integration of new methodologies and technologies into the commercial testing lab.
• Clear Direction & Collaboration: Establish clear goals, distribute workload appropriately, and foster an open, honest, and collaborative work environment.
• Employee Performance: Provide regular feedback on team performance and support ongoing development.
• Budget Management: Prepare and manage the site’s QC budget effectively.
• Data-Driven Decision Making: Utilize statistical methods to analyze data, ensure the best quality control practices, and identify areas for efficiency improvement.
• Team Motivation & Support: Lead, motivate, and mentor the team, clearly communicating task details and goals to optimize performance.
• Regulatory & Customer Interaction: Serve as the analytical subject matter expert (SME) during regulatory inspections and customer audits. Frequently interact with site leadership and customer representatives regarding QC Lab matters.
• Compliance & Procedures: Ensure all procedures, quality standards, and policies align with Tri-Pac’s Quality Management System and current good laboratory practices (GLPs).
• Method Development & Validation: Review and approve method transfer, validation, and analytical reports, and manage laboratory instrument qualifications and protocol updates.
• GMP Compliance: Ensure all lab personnel comply with GMP requirements, and maintain up-to-date training on methods, pharmacopoeias, and related document changes.
• Environmental & GMP Adherence: Follow all environmental training, procedures, and cGMP requirements, and handle internal notifications of environmental events.
• Additional Duties: Perform any other job-related tasks as required.

Education and Experience:

• Minimum: Bachelor's degree in Engineering, Science, or a related discipline (advanced degree preferred).
• Experience: At least 7 years of relevant validation experience in a regulated industry.
• Core Expertise: Proficiency in at least 3 of the following areas: Cleaning Validation, Process Validation, Method Development, Method Validation, Method Transfer.
• Regulatory Knowledge: Familiarity with GMP regulations (e.g., 21 CFR 210, 211, 820), industry guidance (e.g., FDA Process Validation guidance, ISO 13485, PDA Technical Reports).
• Customer & Regulatory Inspections: Experience with customer and regulatory inspections.
• Risk Management: Strong understanding of quality risk management principles and a risk-based C&Q approach.
• Additional Experience: Hands-on validation experience, project management skills, and experience in cosmetic/OTC and personal care production is a plus.

Benefits:

At Tri-Pac, Inc., we offer a competitive salary and a comprehensive benefits package, including unlimited PTO, health, dental, and vision insurance, 401K, life insurance, and both short- and long-term disability. We are committed to your growth, offering continuous training and education assistance to help you thrive in your career.

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Thank you for considering a career with Tri-Pac, Inc.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer.

For Staffing & Recruitment Agencies:

Please note that we do not accept unsolicited CVs or applications from agencies. We are not responsible for any fees related to unsolicited submissions and retain the right to contact candidates presented through such channels.

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