Manufactures, assembles, and labels clinical and commercial products. Operates manual and semi automatic and automated production equipment. Performs all functions under cGMP guidelines.
- 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
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
This position will require some overnight work, conducted about 10 times a year.
University of Massachusetts Medical School - 18 months ago