Quality Control Laboratory Manager

Position Title: Quality Control Laboratory Manager

Reports to: Director of Quality

Direct Reports: Quality Control Chemists, Quality Control Microbiologists, Quality Control Technicians

Basic Function: Supervise laboratory personnel and maintain the Quality Control Laboratory to ensure all products and procedures meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and Customer Expectations

Principal Duties:

• Maintain the laboratory quality management system to ensure compliance with cGMP.
• Establish product test methods and specifications. This includes raw materials, in-process product, finished products and stability samples.
• Audit the Quality Control Laboratory to ensure compliance to SOPs.
• Investigate, assess, and troubleshoot test and/or equipment problems.
• Review Out-of-trend/Out-of-specification results and participate in investigations to determine root cause and CAPA.
• Maintain appropriate laboratory inventory to ensure timely release of materials.
• Participate in method qualifications, validations, and transfers.
• Maintain sample tracking and integrity at all times until analyses are reviewed.
• Ensure analytical equipment is calibrated and well maintained at all times.
• Ensure that laboratory personnel training requirements are met and that training records are current.
• Knowledge and Skill Requirements:
• BS in Chemistry, Biology or a related discipline.
• Knowledge and control of analytical equipment including calibration and maintenance.
• Knowledge of computer software, including relevant applications such as Microsoft Office.
• Knowledge of CGMPs regulations.
• Understanding of quality systems including change control, deviations and CAPAs.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Strong written and verbal language skills to effectively read and write SOPs and related lab reports and communicate with personnel at all levels in the organization.

Salary: DOE

Job Type: Full-time

Pay: From $100,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Weekends as needed

Experience:

• Labatory Manager: 10 years (Required)

Language:

• English (Required)

Work Location: In person

Salary : $100,000