Performs manufacturing operations to produce pharmaceutical products. One day shift, one night shift opportunity available.
Perform production activities including: Line clearances, cleaning, preparing inspection equipment, operation of automated inspection equipment, and manual inspection of product and media filled vials and cartridges.
Operate and maintain production equipment.
Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.
Execute validation protocols for processes and equipment.
Maintain records and a clean environment to comply with regulatory requirements.
Read, Understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
Review/update current SOPs/batch records as well as write new SOPs/ batch records, and protocols.
Lead troubleshooting and process improvement activities including corresponding documentation activities.
Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
Initiate appropriate action when process deviations occur.
Perform OJT for new and developing operators
HS education or equivalent required.
Previous experience in a GMP environment.
Ability to operate all types of production equipment; gown appropriately for production operations. Team player committed to quality and working effectively with others. Motivated self-starter, results oriented, dependable, organized, efficient work traits, disciplined, and able to work with minimal supervision.
Basic math and computer skills and mechanical aptitude.
Ability to lift 40 pounds, stand for long periods of time, work gowned up for long periods of time, maintain good personal hygiene.
Unimpaired manual dexterity.
Vision or corrected vision equal to or better than 20/25
Ability to identify and distinguish colors.
Works under conditions with minor hazards such as working with moving machinery and equipment.
Amylin Pharmaceuticals, Inc. - 2 years ago