Quality Control Lab Manager

Cencora•Columbus, OH

2d•Onsite

About The Position

This role is in support of American Health Packaging, a Cencora business offering pharma packaging services in the US. Under the general direction of the Sr. Manager, Regulatory Affairs & Stability, the Quality Control Lab Manager is responsible for the management of the AHP Quality Control Chemistry and Microbiology Laboratories. Producing and managing the execution of technical method transfers between suppliers and the AHP laboratories, leading investigations of unexpected laboratory results and coordinating communications with suppliers. This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

Requirements

Bachelor’s degree in chemistry or related field required.
Seven or more years’ experience within a pharmaceutical manufacturing (cGMP) laboratory environment.
Working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations.
Experience in pharmaceutical stability testing (HPLC, Dissolution, Related Compounds, etc.), trending analysis and investigation of unexpected results.
Experience with method transfer protocols, stability testing and data analysis for testing of pharmaceuticals.
Good oral, written, communication, and interpersonal skills.
Ability to develop and maintain cooperative working relationships with others.
Effectively interfaces with multiple levels of associates within the organization, including management and plant associates.
Ability to work independently.
Ability to handle a variety of tasks simultaneously.
Attention to detail.
Familiarity with concepts of electronic documentation management systems (EDMS).

Nice To Haves

Experience with MasterControl or other electronic quality management system preferred.

Responsibilities

Directs, leads, trains and mentors the Laboratory Associates.
Provides direction of daily tasks.
Prioritizes workload for department.
Set departmental objectives for strategic alignment to site goals within the Quality Assurance function including monthly metrics and trend data.
Produce and manage the execution of technical method transfer activities between supplier and AHP laboratories.
Oversee the creation of test methods and method transfers to bring additional products into the AHP laboratories.
Lead laboratory investigations for out of trend results and coordinate the communications between supplier and AHP laboratories and document in MasterControl.
Perform trending analysis for laboratory metrics data to identify potential areas of concern in analytical reproducibility.
Manage the Environmental Monitoring program and TOC equipment and water sampling for micro.
Responsible for the laboratory testing of micro samples for LUD product release.
Perform review and entry of stability data.
Support Quality Investigations team with requested analysis.
Utilize process improvements to gain efficiency while maintaining quality.
Assure all associates follow cGMP and safety procedures.
Create, revise and maintain Stability documents using a (DCS) Document Control System such as MasterControl and Stability software such as NovaTek
Ensure stability and release testing activities are compliant with FDA, DEA, other regulatory body requirements as applicable.
Ensure compliance with local and corporate policies and procedures.
Oversee stability and release testing for drug products in accordance with compendial and global requirements, as applicable.
Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.
Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable.
Perform review of stability and release tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately.
Prepare lab reports as required.
Assist with root cause investigations for quality incidents.
Maintain Quality System records and ensure completeness and accuracy.
Coordinate with department management to identify and implement compliant process improvements.
Clarify regulations, policies, and procedures to internal teams as applicable.
Coordinate with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections.
Conduct follow-up checks on the effectiveness of corrective actions
Performs other duties to support Quality Systems and Regulatory Affairs department as assigned.
Develop clear objectives for team members in support of their development, progression, and career path.
Conduct performance management reviews.