Job Summary:

The Quality Control Manager is responsible for managing laboratory personnel and maintaining the laboratory to ensure all products and procedures meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.

Supervisory Responsibilities:

• Maintain the laboratory quality management system to ensure compliance with cGMP.
• Audit the Quality Control Laboratory to ensure compliance to SOP’s.
• 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.
• 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.
• Interview, hire, and train new staff.
• Provide constructive feedback and retraining as needed.
• Handles discipline of employees in accordance with company policy.

Duties/Responsibilities:

• 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 SOP’s.
• Maintain appropriate laboratory inventory to ensure timely release of materials.
• Participate in method qualifications, validations, and transfers.
• Other duties as assigned.

Required Skills/Abilities:

• Excellent verbal and written communication skills in English.
• Excellent management and teamwork skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Ability to function well in a high-paced and at times stressful environment.
• Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
• Knowledge and control of analytical equipment including calibration and maintenance.
• Understanding of quality systems including change control, deviations and CAPAs.
• Ability to handle multiple tasks concurrently and complete them in a timely manner.

Experience:

• Pharmaceutical Labatory Manager: 5 years (Required)
• Chemistry/Pharmaceutical: 5 years (Required)
• CGMP: 5 years (Required)
• FDA regulations: 5 years (Required)