POSITION OBJECTIVE: Supervise Incoming Quality Control (IQC) personnel and activities performed in the IQC areas and laboratories as applicable.

Essential Job Functions/Responsibilities

  • Provide GMP guidance and training for IQC personnel.
  • Ensure a safe work environment and material handling for IQC personnel.
  • Review, approve, and release incoming materials for production use including components, labels, bulk material, pouches, boxes, and including packaging inserts.
  • Monitor inventory levels to create priorities for IQC technicians to support production, clinical needs, ointment production, and other aspects of the business.
  • Monitor and facilitate Quality Orders creation and review in QAD.
  • Facilitate outside laboratory testing to create quotations, review compendial verification procedures, conduct/review investigations, and support release of material in a timely manner to support several aspects of the business.
  • Serve as subject matter expert for IQC and related processes.
  • Update procedures and specifications as needed through MasterControl program.
  • Oversee Incoming QC, APS Foxy deliveries, OST testing, sample label creation/distribution.
  • Manage personnel, support budget planning, develop and maintain IQC work schedules.
  • Promote and implement personnel engagement and development.
  • Complete staff assessments and reviews as required ensuring competencies are maintained.
  • Provide input into continuous improvement and metric development and maintenance.
  • Provide a fair assessment and execute processes in hiring new staff members.
  • Provide support for customer and manufacturing related needs while maintaining a high level of professionalism.
  • Review and approve new equipment protocols and method validation, qualification, and method transfer protocols for IQC related processes.
  • May perform other duties as assigned.

Required Education & Qualifications

  • Bachelor degree in an applicable life-science with a minimum of 5 years of experience in the pharmaceutical manufacturing industry or an Associate degree in an applicable life science with a minimum of 10 years of experience or high school diploma with minimum of 15 years’ experience in the pharmaceutical manufacturing industry.
  • Strong leadership with experience in supervising and developing employees and teams.
  • Excellent verbal and written communication skills.
  • Ability to effectively communicate to multiple levels within the organization.
  • Strong focus on quality and safety in a pharmaceutical environment.
  • Experience in 5S and lean initiatives preferred.

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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