Manufacturing Process Operator III (Compounder) - Second Shift

Clarence, NY, United States Full Time

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Our Manufacturing Process Operator III is responsible for ensuring the accurate production and documentation of pharmaceutical products and maintaining a safe manufacturing environment.

This is a second shift position - hours are 2 PM to 10:30 PM.

Essential Job Functions/Responsibilities

  • Compound and package pharmaceutical products into various formats to meet company GMP & SOP requirements
  • Weigh, verify, and formulate raw materials according to the Manufacturing Work Order instructions
  • Manufacture bulk drug product under stringent GMP and SOP conditions
  • Accurately enter manufacturing data to production documents, log books and records
  • Work in an aseptic production environment
  • Must be able to work in full clean room attire (i.e., full hooded cleanroom gown)
  • Ensure that materials and equipment in the Manufacturing area are maintained in accordance with GMPs and SOPs
  • Monitor product quality
  • Read and comply with all Standard Operating Procedures and Good Manufacturing Practices
  • Participate in new product transfer programs working directly with the customer
  • Assist in the creation of new manufacturing process documentation; procedures, policies and batch records
  • Use all approved and issued Personal Protective Equipment as directed by policy and procedures
  • Participate in training new employees
  • Contribute to achieving continuous improvement
  • Long periods standing in one place; processing product on moving belts
  • Repetitive hip and upper body twisting movements
  • Able to lift up to 25 lbs., and move materials weighing up to 400 lbs. using the appropriate equipment
  • Assist in other daily activities required of the area as assigned

Required Education & Qualifications

  • Minimum two (2) year technical degree is preferred. Equivalent experience will also be considered
  • 3+ years working in a Pharmaceutical manufacturing environment with at least two (2) years experience working in aseptic class 5 environment
  • Must be Aseptic gown qualified
  • Working knowledge of cGMP
  • Ability to understand and follow SOP
  • Flexible with the ability to adapt, respond quickly and manage change in a fast paced team oriented environment
  • Demonstrated effective written and verbal communication skills is required, with the ability to read and comprehend SOPs and other written documentation
  • Able to utilize a computer for data entry is required, knowledgeable in Windows, Word, and Excel desired
  • Good written and verbal communication with various organizational levels is necessary

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