QC Microbiology Manager

Cardinal Health•Indianapolis, IN

About The Position

The QC Microbiology Manager oversees microbiology laboratory systems to ensure that laboratory data are produced in accordance with applicable regulations and company policies and procedures. The role oversees the Environmental Monitoring Program and recommends approval or rejection of starting materials, intermediate products, and finished products. It develops and applies practices that help laboratories meet customer and regulatory standards cost-effectively, and collaborates with validation and maintenance teams on laboratory equipment conformance. The manager is responsible for inspections, investigations, and sampling to monitor factors affecting product quality; ensuring required testing is performed and records are evaluated; and conducting or assisting with laboratory investigations of discrepancies. The role works with management to ensure corrective and preventive actions are implemented on time, promotes effective communication and escalation of quality issues, advises on laboratory supply purchases that affect quality, and supports staff training and development. The manager also supervises department operations and professional employees, manages the area’s budget and resources, and supports company safety, quality, ethics, environmental, vision, and strategy policies.

Requirements

Bachelor’s degree in Microbiology, Biology, or a related science field.
At least 7–10 years of relevant work experience with 21 CFR 210 and 211 in an FDA-regulated pharmaceutical or medical device industry.
Experience with equipment qualification, software validation, test method validation, environmental monitoring, and/or process validation.
Understanding of the validation and technology transfer process.
Experience writing procedures and reports and executing laboratory tests.
Ability to work well with others and contribute to a team environment.
Detail-oriented, organized, able to multitask, self-starting, and self-motivated.
Proficiency in Microsoft Word and Microsoft Excel.
Strong technical writing skills.

Nice To Haves

Advanced degree.

Responsibilities

Oversee microbiology laboratory systems to ensure laboratory data comply with applicable regulations and company policies and procedures.
Oversee and maintain the Environmental Monitoring Program as required.
Recommend approval or rejection of starting materials, intermediate products, and finished products.
Develop and apply practices that enable the laboratory to meet or exceed customer and regulatory standards cost-effectively.
Collaborate with validation and maintenance teams regarding laboratory equipment conformance with applicable procedures and good practices.
Conduct inspections, investigations, and sampling to monitor factors that may affect product quality.
Ensure required testing is carried out and associated records are evaluated.
Assist with or conduct laboratory investigations of discrepancies and work with management to ensure corrective and preventive actions are implemented in a timely manner.
Keep current with microbiology developments by reading technical literature and attending technical meetings.
Recommend improvements to laboratory performance to management.
Ensure proper laboratory hygiene and monitor storage conditions for laboratory materials and products.
Foster timely and effective communication and escalation of quality issues to appropriate management levels.
Advise on the purchase of laboratory supplies that directly affect quality.
Assist with training and development of laboratory personnel.
Prepare and review team members’ personal development plans and identify and provide appropriate training.
Ensure Safety, Quality, and Site actions are completed effectively and on time, with an escalation process for quality issues.
Manage department operations, supervise employees and other assigned staff, manage the area’s budget, and allocate resources.
Support and adhere to company Safety, Quality, Ethics, and Environmental Management System policies and procedures, as well as the company’s vision and strategy.
Perform other job duties as assigned.