Quality Control Lab Manager

3w3 weeks ago

AmerisourceBergen

Columbus, US · Full-time · $115,000 – $145,000

About this role

This role is in support of American Health Packaging, a Cencora business offering pharma packaging services in the US. The Quality Control Lab Manager manages the AHP Quality Control Chemistry and Microbiology Laboratories, ensuring compliance with division, corporate, and government regulatory requirements.

Day-to-day responsibilities include directing, training, and mentoring Laboratory Associates while prioritizing workload for the department. The manager produces and manages technical method transfers between suppliers and AHP laboratories, and leads investigations of unexpected laboratory results.

The position coordinates communications between supplier and AHP laboratories, documented in MasterControl, and performs trending analysis for laboratory metrics to identify potential reproducibility concerns. This compliance-critical role oversees the Environmental Monitoring program and TOC equipment and water sampling for micro.

This manager sets departmental objectives for strategic alignment to site goals within the Quality Assurance function, including monthly metrics and trend data. The role offers the opportunity to drive process improvements to gain efficiency while maintaining uncompromising quality standards in a pharmaceutical environment.

Requirements

Experience managing a Quality Control Chemistry and Microbiology laboratory in a pharmaceutical or regulated industry
Knowledge of cGMP, FDA, and DEA regulatory requirements
Ability to oversee stability and release testing for drug products in accordance with compendial and global requirements
Experience developing, revising, and reviewing standard operating procedures (SOPs) and work instructions (WIs)
Proficiency with document control systems such as MasterControl and stability software such as NovaTek
Demonstrated ability to lead investigations of unexpected laboratory results and perform trending analysis for laboratory metrics
Experience with technical method transfers between laboratories

Responsibilities

Direct, lead, train, and mentor the Laboratory Associates
Provide direction of daily tasks and prioritize workload for department
Produce and manage the execution of technical method transfer activities between supplier and AHP laboratories
Lead laboratory investigations for out of trend results and coordinate communications between supplier and AHP laboratories in MasterControl
Manage the Environmental Monitoring program and TOC equipment and water sampling for micro
Perform review and entry of stability data and support Quality Investigations team with requested analysis
Create, revise, and maintain Stability documents using MasterControl and NovaTek software