Quality and Lab Specialist
Under general direction of the Laboratory Manager, and reporting to the Laboratory Supervisor, you will be primarily responsible for Quality Control testing in launching finished product; routine testing of finished product and compliance with cGMP's. In addition you will support the regulatory requirements of finished product, supplier management and investigation of product issues.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate's responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
PRIMARY DUTIES AND RESPONSIBILITIES:
Ensures compliance with cGMP's, Environmental, Health & Safety regulations.
Executes all Quality Control activities to ensure timely & compliant launch of finished products.
Executes all routine Quality Control testing to ensure timely & compliant release of finished products.
Executes the finished product Exception Program.
Supports regulatory requirements of finished products
Supports the timely receipt and release of finished products.
Prepares and executes method development, validation plans and protocols for the laboratory.
Supports the document control system & record retention.
Ensures laboratory equipment is calibrated & properly maintained at all times
Executes and supports batch record reviews to ensure timely release of finished product according to schedule.
Develops and implements Standard Operating Procedures.
Promotes the maintenance of a safe, accident free and healthy work environment.
Performs related duties as assigned.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
BSc in a scientific discipline; minimum of two (2) years in a cGMP facility in a Quality Control role. Experience in HPLC (High Performance Liquid Chromatography) is required.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.