Quality Manager

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

Job Description:

The Quality Manager will have strong leadership and communication skills with demonstrated team building success and a passion for building, developing and leading strong diverse teams. He/she is a creative conceptual thinker with strong analytical and problem-solving skills and is comfortable dealing with technical issues. Must be decisive with a bias to action.

Responsibilities: 

• Ensure compliance with all applicable Customer, FDA, Health Canada and EMA regulations. 
• Provide guidance to site on quality compliance standards and expectations. 
• Manage the Batch Release Process: completes quality assurance operational requirements by scheduling and assigning employees and providing adequate oversight to ensure that requirements are met. 
• Develop and utilize global key performance indicators (KPIs) to monitor quality performance and effectively manage quality effectiveness and non-conformances. 
• Manage the site’s Batch Master Processing Records, Packaging Control Data & Specification process. 
• Manage the site's Customer Complaint, Non-Conformance, CAPA and Internal Audit program. 
• Manage the site’s Analytical and Microbiological laboratories and their associated testing. 
• Manage the site’s In-Process and Incoming Inspection processes. 
• Manage the site’s Quality Assurance and Product release processes.
• Assist with review and approval of quality agreements and act as liaison with all clients on commercial quality topics. 
• Oversee compliant document management and retention programs. 
• Streamline departmental procedures and ensure staff are trained in pursuit of robust compliance and operating efficiency. 
• Ensure site-wide training is efficient and documentation is adequately maintained and retrievable. 
• Author, review, and approve applicable, SOPs, WI’s, Investigations, year-end inventory numbers, etc. 
• Direct reports from Quality Manager and indirect reports from Quality team including Quality Leads, Technicians, Inspectors, and others. 
• Lead for regulatory and customer audits.

Education and/or Experience:

• Bachelor’s Degree Required 
• 10 years in quality assurance and/or Minimum 5 years in managerial leadership position.
• Knowledge of GMP/GDP/USP/CFR/GLP/FDA regulations.
• Previous people leadership roles with multi-shift direct reports. 
• Proven progressive leadership roles within quality organizations with a successful track record.

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

www.tri-pac.us

Thank you for your interest and consideration of a career with Tri-Pac, Inc.

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

To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

COVID-19 considerations:
All employees are mandated to wear masks while in any of the facilities. All employees are mandated to wear face shields, booties, hair nets and other PPE as required.