POSITION OBJECTIVE: This position is responsible for the performance of all manufacturing activities in the Controlled/Non-Classified and Classified areas of Athenex Oral Dosage Packaging Facility, (AODPF). The Operator performs various primary packaging activities including the Blistering, Pouching and Bottling of capsules/tablets, as well as secondary packaging including card assembly, heat sealing, lot coding, labeling, kitting and final pack-out of finished goods. The Operator coordinates with the Operations Manager to ensure production is completed in compliance with cGMPs and department SOPs.

This is a first shift position. Hours are 7 AM to 3:30 PM, Monday through Friday.

Essential Job Functions/Responsibilities:

  • Execute production activities through various forms of batch traceability documentation including Laboratory Notebooks, Protocols and Master Batch Records
  • Provide input on updates to Standard Operating Procedures (SOPs), Master Batch Records and other departmental documentation.   
  • Understand and Train on procedures across multiple Athenex locations to allow for support if needed
  • Operate ink jet coder and perform applicable cleanings
  • Review and maintain logbooks, production batch records, and associated documents to comply with SOP guidelines
  • Perform routine cleanings within classified areas to maintain active state while wearing appropriate PPE and adhering to chemical rotation       
  • Accurately perform inspections/reconciliation of semi-finished goods, packaging components and Finished Goods
  • Perform tasks in the production / packaging of oral dosage product to provide on-time delivery to customers
  • Coordinate transfer of in-process samples across multiple sites to initiate product testing
  • Maintain a clean and organized work area at all times
  • Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies; wear appropriate PPE for the operation being performed
  • Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department
  • Able to lift, push, and /or pull up to 50 pounds
  • Able to stand or walk up to 70% of day at certain times
  • Troubleshoot equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime
  • Other projects as may be assigned.

Required Education and Qualifications:

  • High school diploma or equivalent required
  • Minimum 6 months experience in a manufacturing or production related role preferred, an FDA regulated industry is a plus
  • Knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities
  • Strong knowledge of finished goods and production reconciliation methods
  • Effective and efficient operation of manual production equipment
  • Demonstrate effective written and verbal communication and interpersonal skills
  • Ability to quickly make decisions and understand the impact on processes and employees
  • Strong team-oriented work ethic
  • Able to lift, push, and /or pull up to 50 pounds
  • Able to stand or walk up to 70% of day at certain times
  • Detail-oriented and self-motivated 
  • Excellent hand-eye coordination and manual dexterity
  • Excellent math skills: ability to add, subtract, multiply, and divide
  • Ability to read, comprehend, write, and communicate effectively in English
  • Ability to carry out detailed written or oral instructions
  • Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment

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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