QC Microbiology Manager

Cardinal Health•Indianapolis, IN

7d•$106,700 - $152,400

About The Position

The QC Microbiology Manager oversees microbiology laboratory systems to ensure laboratory data are generated in accordance with applicable regulations and company policies and procedures. The role manages department operations and professional employees, supports operational excellence, develops processes and procedures, manages the area budget and resources, and helps team members develop through goals, assignments, and training. The manager works with customer groups and other teams to address business and quality needs and ensures effective communication and escalation of quality issues. The position oversees the Environmental Monitoring Program; recommends approval or rejection of starting materials, intermediate products, and finished products; and develops cost-effective practices that meet or exceed customer and regulatory standards. It collaborates with validation and maintenance teams regarding laboratory equipment, oversees inspection and sampling activities, ensures required testing and record evaluation, and assists with laboratory investigations and timely corrective and preventive actions. The manager also monitors laboratory hygiene and storage conditions, advises on quality-related laboratory supply purchases, stays current with microbiology developments, and supports laboratory personnel training and development. Responsibilities are carried out in accordance with company safety, quality, ethics, and environmental policies and procedures, and the company’s vision and strategy. The role also ensures safety, quality, and site actions are completed effectively and in a timely manner. Other duties may be assigned.

Requirements

Bachelor of Science 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 effectively in 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 preferred.

Responsibilities

Oversee microbiology laboratory systems to ensure generated 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 cost-effective laboratory practices that meet or exceed customer and regulatory standards.
Collaborate with validation and maintenance teams to assess laboratory equipment conformance with applicable procedures and good practices.
Conduct or oversee inspections, investigations, and sampling to monitor factors that may affect product quality.
Ensure required testing is completed and associated records are evaluated.
Assist with or conduct laboratory investigations of discrepancies and work with management to implement corrective and preventive actions in a timely manner.
Stay informed about microbiology developments by reading technical literature and attending technical meetings.
Recommend improvements to laboratory performance.
Ensure proper laboratory hygiene and monitor storage conditions for materials and products used in the laboratories.
Promote timely and effective communication and escalation of quality issues to appropriate management levels.
Advise on purchases of laboratory supplies that directly affect quality.
Assist with training and development of laboratory personnel.
Produce and review team members’ personal development plans and identify and provide appropriate training.
Ensure safety, quality, and site actions are completed effectively and in a timely manner, with an escalation process for quality issues.
Manage department operations, staff, budgets, and resources; develop processes and procedures to implement functional strategies.
Perform other duties as assigned.