Manufacturing Technician II

Job description

Overview

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.

Responsibilities

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
• Perform Cleaning and Sterilization of equipment
• Perform 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
• Set up, operate, maintain, monitor and troubleshoot manufacturing equipment
• Preform visual inspection of final product vials
• Perform visual inspection of final product container labeling for compliance with master specifications
• Perform the final destruction of product
• Perform the storage and warehousing of final product containers and components
• Review of batch records and logbooks
• Perform additional job duties as required

Qualifications

REQUIRED QUALIFICATIONS:

 

·         Requires a high school diploma with a minimum 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 procedures and initiate appropriate corrective action

·         Ability to troubleshoot within scope of training

·         Computer literate and proficient in MS Word, Excel and other relevant electronic systems

·         Demonstrated ability to multitask and consistently meet deadlines

·         Possesses strong attention to detail, ability to maintain accurate written records

·         Ability to communicate effectively with others

·         Ability to work 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

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