Manufacturing Process Operator II - First Shift

Athenex, Inc. Amherst , OH 44001

Posted 7 months ago

Manufacturing Process Operator II - First Shift

Amherst, NY, United States Full Time

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POSITION OBJECTIVE: Support Production activities at the Athenex Pharma Solutions Amherst, NY facility. This position will also be responsible for ensuring processes and products are in compliance with current Good Manufacturing Practices and 21CFR 210/211.

Key Job Functions/Responsibilities

  • Package pharmaceutical products into various formats to meet company GMP & SOP requirements

  • Perform set-up, operation and troubleshooting of semi-automated production lines

  • Accurately enter manufacturing data to production documents, log books and records

  • Assist in retrieval and compilation of metric data related to production throughput. Track and identify other areas as necessary

  • Build and maintain collaborative working relationships within the organization

  • Maintain department readiness for internal and external audits

  • Must be able to work in full clean room attire (i.e., full hooded cleanroom gown)

  • Assist Operations and Production Site Manager to aid in problem solving for critical issues

  • 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

  • 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

  • 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 and Qualifications

  • High School Diploma (or equivalent) with 3+ years of relevant work experience preferred

  • Proficient in Microsoft Suite (Word, Excel, PowerPoint, Project). Experience with electronic document management and tracking systems a plus.

  • Strong written and verbal communication skills is required, with the ability to read and comprehend SOPs and other written documentation

  • Can manage multiple projects under tight timelines, working independently and collaboratively

  • Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment

  • Knowledge and experience with use of electronic quality management systems preferred

  • Ability to educate and train junior staff

  • 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

Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.


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Manufacturing Process Operator II - First Shift

Athenex, Inc.