Position Objective:         This position is responsible for the performance of all manufacturing activities in the Controlled/Non-Classified and Classified areas of the plant and completion of all Finishing operations for Ointment production. The Operator performs all final packaging and serialization activities. The Operator coordinates with the area Lead to ensure production is completed in compliance with cGMPs and department SOPs.

  

This is a temporary assignment projected to be approximately 4 months in length.

Monday through Friday 7am to 3:30pm.


Essential Job Functions/Responsibilities

• Complete final packaging of ointment packets and perform serialization activities

• Strict adherence to FDA Track and Trace serialization rules and requirements

• Execute job duties as described in departmental SOPs and in accordance with relevant cGMP guidelines

• Document all necessary information in Master Batch Records and area logbooks, as per Good Documentation Practices SOP

• Accurately perform inspections/reconciliation of packaging components

• Maintain accurate accounting of all Work-in-Process materials, performing detailed reconciliation prior to movement to next process step

• Review and maintain logbooks, production batch records, and associated documents to comply with SOP guidelines

• 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


Required Education and Qualifications

•             High school diploma or equivalent required

•             6+ months of manufacturing/production experience in pharmaceutical or related FDA regulated industry required

•             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 and automated production equipment

•             Demonstrated 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

•             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

•            This is a safety sensitive position and/or a position which has the potential to significantly impact the health or safety of other employees or members of the public. It requires passing a pre-employment drug screen in compliance with federal drug testing rules.   




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.


   This is a safety sensitive position and/or a position which has the potential to significantly impact the health or safety of other employees or members of the public. It requires passing a pre-employment drug screen in compliance with federal drug testing rules.   

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