POSITION OBJECTIVE: Performing IQC activities to ensure timely release of packaging components and raw materials to support manufacturing needs for pharmaceutical products.

 

REPORTS TO: IQC Supervisor

 

Essential Job Functions/Responsibilities

  • Supports scheduling of all incoming raw material and component testing with IQC supervisor and Purchasing department.
  • Supports the release of all packaging components.
  • Manage and coordinate all the in-house and off site testing (OST) of raw materials and components.
  • Assists in managing IQC workflow of daily tests and activities to meet departmental goals and support production needs with timely releases of incoming products.
  • Assists management in writing and revising departmental policies, procedure and product specifications.
  • Ensures that assigned trainees receive appropriate training and information necessary to conduct their activities.
  • Conducts sampling and inspections of all incoming materials to support multiple facets of the company.
  • Reviews and verifies sampling, inspections and testing performed by technicians.
  • Ensures a safe work environment for all personnel.
  • Conducts investigations and CAPAs in a timely manner.
  • Recognizes nonconforming testing results and reports them promptly to IQC/QC management.
  • Upholds departmental standards as required in a GMP/GLP environment.
  • Support Finished Goods and Stability sample flow and testing as needed.
  • Provides input into continuous improvement and metric development and maintenance.
  • Performs safe sampling of pharmaceutical ingredients and excipients for In-house and Outside Laboratory testing.
  • Use of multiple level instrumentation, including FTIR, UV vis spectrophotometer, Karl Fisher units, balances, pH meters, etc.
  • Works as an effective team member to meet departmental objectives, sharing knowledge with the team members and across the department.
  • May perform other duties as assigned

 

Required Education & Experience

  • Bachelor’s degree in an applicable life-science with a minimum of 3 years experience in a GMP facility industry

OR

  • Associate degree in an applicable life science with a minimum of 5 years of experience in a GMP facility.


Required Skills & Abilities:

  • Able to adapt and respond quickly in a fast-paced environment.
  • Strong attention to detail with the ability to follow standard operating procedures.
  • Excellent organizational, verbal and written communication skills.
  • Experience or understanding of cGMPs and USP testing (preferred).
  • Technology Skills (Windows, Word, Excel, LMS, Master Control). (preferred)
  • Ability to effectively communicate to multiple levels within the organization.
  • Ability to work on multiple projects simultaneously.

 

Working Conditions:

  • This is an office-based position
  • Frequent standing, walking, sitting, bending, stooping, listening, and talking.
  • Must have a valid drivers license for travel between local sites, up to 10% of the time.
  • Frequent use of personal computer and office equipment.
  • Frequent work under deadlines supporting production including as needed on weekends.
  • Occasionally may support off hours based on departmental needs.
  • Possible exposure to standard laboratory chemicals and reagents, etc.
  • Occasionally lift up to 40lbs.


Company Benefits

  • Hourly rate starting at $18 per hour; increased based on experience
  • Medical, Dental, Vision, 401k, Paid Time Off, Life Insurance, Short-Term Disability, Long-Term Disability, and more!



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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