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GENERAL SUMMARY OF POSITION: 

Manufactures, assembles, and labels clinical and commercial products. Operates manual and semi automatic and automated production equipment. Performs all functions under cGMP guidelines.  

MAJOR RESPONSIBILITIES:

•      Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients  and quantities

•      Prepare buffers, solutions and media as required

•      Conduct integrity testing of filters

•      Assist in Cleaning and Sterilization of equipment

•      Assist in clinical and commercial manufacturing operations were applicable

•      Maintain accurate and legible records and other documentation as required

•      Perform daily maintenance in production facility (decontaminate trash, clean benches, stock supplies)

•      Perform defined  Environmental Monitoring in manufacturing facilities

•      Sets up, operate, maintain, monitor and troubleshoot manufacturing equipment

•      Perform visual inspection of final product container labeling for compliance with master specifications.

•      Perform visual inspection on final product vials

•      Assist in the final destruction of product

•      Assist in the storage and warehousing of final product containers and components.

•      Assist in the review of batch records and logbooks

•      Perform additional job related duties as required

REQUIRED QUALIFICATIONS:

• Requires a high school diploma with a minimum 0-2 years of relevant experience
• Ability to follow verbal and written instructions precisely
• Ability to adapt to a cGxP regulated environment
• Demonstrated ability to recognize deviations from standard procedure
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Demonstrated ability to consistently meet deadlines
• Possesses attention to detail, ability to maintain accurate written records
• Ability to communicate effectively with others
• Ability to work effectively both independently and as a member of a team
• Experience in the following areas is preferred: manufacturing
• No travel required, standard work hours may require weekend and off shift hours as required

• Must be able to lift 50 lbs minimum using proper lifting technique