QC Chemistry Manager

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry.

Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL.

Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.  Position Summary cGMP Consulting is seeking an experienced QC Manager to support the Chemistry Laboratory which functions to support the manufacturing of aseptically processed and terminally sterilized pharmaceutical products.

This individual will provide technical leadership, daily oversite, and subject matter expertise needed to manage the QC chemistry laboratory functions :

• Responsibilities  The essential functions include, but are not limited to the following :   Provide the necessary chemistry expertise, leadership, and guidance to ensure operations and staff implement appropriate aseptic processing controls, equipment controls, and chemistry controls to meet regulatory requirements.
• Provide the expertise to support product dispositions, investigations, risk analyses, and mitigations related to aseptic processing and chemistry testing.
• Leads collaboration between functions to maintain and continually improve strategies related to laboratory practices and aseptic processes.
• Supervises, leads, and coaches laboratory staff to ensure all activities are performed and documented according to policies, procedures and consistent with cGMP and regulatory requirements.
• Accountable to implement the QC chemistry functions and associated quality systems, ensure communication and resource planning, plan and manage budget, and meet regulatory requirements.
• Endure department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
• Responsible for ensuring that Health, Safety and Environmental requirements are med under ISO 14001 standards.
• Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
• Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001 standards.  Requirements  Bachelors’ degree in Chemistry, or a related field of study.  Minimum 5 years pharmaceutical manufacturing experience; minimum 5 years experience in quality management, lab management.
• Experience with high performance teams and development of quality staff is desirable.
• Strong interpersonal skills, must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately.
• Demonstrate business acumen with a proven track record of best practice implementation and accomplishments involving quality, manufacturing, engineering, and warehousing.
• Ability to work both independently and in partnership with others, proven ability to use initiative and drive to achieve results.
• Strong conflict resolution skills.

Compensation and Benefits  Expected pay range per year :