Senior Quality Engineer

Tri-Pac, Inc., a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for Senior Quality Engineer.

Job Description: The Senior 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 the 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 the Quality Manager and indirect reports from the Quality team, including Quality Leads, Technicians, Inspectors, and others. Lead for regulatory and customer audits Education & Professional Experience Bachelor's degree required Minimum of 8 years in Quality Assurance, with at least 5 years in a leadership capacity Demonstrated expertise in regulatory standards, including GMP, GDP, USP, CFR, GLP, and FDA guidelines Proven success in leading teams across multiple shifts, with direct supervisory responsibilities Progressive leadership experience within quality-focused organizations, marked by a strong record of achievement and continuous advancement

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) 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 applications.