Job Description

Quality Control (QC) Lab Manager

Tri-Pac, Inc., a contract development and manufacturing organization (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Quality Control (QC) Lab Manager to join our fast-growing team.

Build a Career You’re Proud Of – with a Team That Supports You.

At Tri-Pac, you’ll find opportunities to expand your skill set, collaborate with a dedicated group of professionals, and contribute to high-quality product development. We believe in fostering professional growth and personal well-being, making this the ideal place to take your career to the next level.

Job Description

Overall Summary

In this role, you will be responsible for the smooth operation of our Quality Control (QC) laboratory, including method development, validation, transfer, and testing of materials. You will ensure consistent product quality and efficiency through continuous improvement, compliance with regulatory standards, and maintenance of Tri-Pac’s Quality Management System. You will also review and approve protocols, reports, deviations, and all QC-related documentation, while coordinating communications between management, production, and other operational teams.

Key Responsibilities

Team Leadership & Development

• Coach and develop a self-sufficient lab team, ensuring proper knowledge transfer and integration of new methodologies and technologies.

Clear Direction & Collaboration

• Establish clear goals, distribute workloads effectively, and nurture an open, honest, and collaborative work environment.

Employee Performance

• Provide regular performance feedback and support ongoing development for all lab team members.

Budget Management

• Prepare and manage the QC budget efficiently, aligning resources with operational needs.

Data-Driven Decision Making

• Utilize statistical methods to analyze data, refine quality control practices, and drive efficiency improvements.

Team Motivation & Support

• Lead, motivate, and mentor the team; communicate tasks and goals clearly to optimize overall performance.

Regulatory & Customer Interaction

• Serve as the analytical subject matter expert (SME) during regulatory inspections and customer audits; liaise with site leadership and customer representatives on QC Lab matters.

Compliance & Procedures

• Ensure all lab activities align with Tri-Pac’s Quality Management System, current good laboratory practices (GLPs), and applicable quality standards.

Method Development & Validation

• Oversee and approve method transfers, validations, and analytical reports; manage laboratory instrument qualifications and protocol updates.

GMP Compliance

• Ensure all QC personnel comply with GMP requirements; maintain updated training on testing methods, pharmacopoeias, and documentation changes.

Environmental & GMP Adherence

• Follow environmental training, procedures, and cGMP requirements; manage internal notifications for any environmental events.

Additional Duties

• Perform other job-related tasks as necessary to support laboratory and organizational objectives.

Education & Experience

• Minimum Education : 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 three 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), FDA Process Validation guidance, ISO 13485, and PDA Technical Reports.
• Inspections : Previous experience with customer and regulatory inspections.
• Risk Management : Strong grasp of quality risk management principles and a risk-based C&Q approach.
• Additional Experience : Hands-on validation expertise, project management skills, and experience in cosmetic/OTC or 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
• 401(k)
• Life Insurance
• Short- and Long-Term Disability
• Continuous Training & Education Assistance – to support your ongoing professional growth

Thank you for considering a career with Tri-Pac, Inc., an Equal Employment Opportunity / Affirmative Action Employer.

If you’re ready to build a career you’re proud of – with a team that supports you , we invite you to apply today. Visit us at to learn more.

Note to Staffing & Recruitment Agencies

Tri-Pac, Inc. does not accept unsolicited CVs or applications from agencies. We are not responsible for any fees related to unsolicited submissions and reserve the right to contact candidates presented through such channels without obligation.

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