Position Overview
Assures consistent quality of production by developing and enforcing good automated 
manufacturing practice (GAMP) systems; validating processes; providing documentation; 
managing staff.

Reports to
Director of Manufacturing

Essential Duties and Responsibilities
DUTIES AND RESPONSIBILITIES 
•	Achieves quality assurance operational objectives by contributing information and 
analysis to strategic plans and reviews; preparing and completing action plans; 
implementing production, productivity, quality, and customer-service standards; 
identifying and resolving problems; completing audits; determining system improvements; 
implementing change..
•	Validates quality processes by establishing product specifications and quality 
attributes; measuring production; documenting evidence; determining operational and 
performance qualification; writing and updating quality assurance procedures.
•	Prepares quality documentation and reports by collecting, analyzing and 
summarizing information and trends including failed processes, stability studies, recalls, 
corrective actions, and re-validations.
•	Updates job knowledge by studying trends in and developments in quality 
management; participating in educational opportunities; reading professional publications; 
maintaining personal networks; participating in professional organizations.
•	Enhances department and organization reputation by accepting ownership for 
accomplishing new and different requests; exploring opportunities to add value to job 
accomplishments.
•	Other duties as assigned.
SKILLS AND QUALIFICATIONS
•	Ability to work independently and to multi task.
•	Good communication skills.
•	Ability to work under pressure.

JOB TYPE:Full-time 

Work Environment and Physical Demands
	Work is generally performed in an office environment. 
	Regular and predictable attendance is required.
	Ability to sit for prolonged periods of time in front of a computer.
	Visual and hearing acuity.