POSITION OBJECTIVE: Responsible for the coordination of quality management system electronic documents and activities. Documents include but are not limited to Standard Operating Procedures (SOPs), Polices, Protocols, Training Curricula, and Quality Event documents. Ensures documentation is compliant with Athenex policies, current Good Manufacturing Practices, other pertinent regulatory requirements, and provide QA support for internal Quality Systems.

 

REPORTS TO:  Director of Validations

 

MANAGES: Position has no direct reports

 

Essential Job Functions/Responsibilities

  • Performs activities related to the electronic and paper Quality Management System documentation and training system (MasterControl).
  • Quality Assurance representative and Subject Matter Expert for MasterControl application across multiple sites.
  • Creates and manages workflows for new and revised documents in electronic management system, including but not limited to: new document preparation, routing, issuance, revision, archival, periodic review of controlled documents following procedure. 
  • Creates and maintains electronic training curricula for Athenex personnel based on organizational and departmental requirements. Maintains training metrics and reports on compliance rates.
  • Reviews content and formatting to ensure compliance to assist in management approval.
  • Routes documents for approval in designated work flows following SOP and assists personnel in routing where required.
  • Quality documents include but are not limited to Standard Operating Procedures (SOP) and associated Forms, Protocols, Work Instructions, Specifications, Risk Assessments and Change Controls. Quality Events include but are not limited to current and future planned and unplanned Deviations, Corrective and Preventative Action (CAPA), Extension Requests.
  • Support compliance review of general quality system documents (e.g., change controls, work records, working documents).
  • Archives controlled documents as needed (organizes and archives records, both paper and electronic).
  • Provides limited user administration assistance to global personnel: this includes but is not limited to new user account creation, password resets, permissions updates.
  • Provides system metrics on quality events as requested to support regulatory or internal audits, management review, and annual product review.
  • May perform other duties as assigned.

 

Required Education & Experience

  • Associates degree from accredited college/university; Experience in lieu of degree may be considered.
  • Minimum of 3 years of related document coordination experience
  • Experience in a regulated environment strongly preferred.
  • Knowledge of electronic documentation, training and/or quality management systems.
  • Knowledge of GMPs, documentation processes/requirements
  • Proficiency with Microsoft Office

Required Skills & Abilities:

  •  Excellent interpersonal skills, with direct and positive experience in written and verbal communications with internal customers and management.
  • Ability to manage multiple tasks, prepare metrics and meet deadlines.

 

 Working Conditions:

  • Primary work area is an administrative setting.
  • Prolonged periods sitting at a desk and working on a computer
  • Travel between Clarence, NY and Buffalo, NY sites is required early on for training opportunities. Job is permanently located in Buffalo, NY facility. 
  • Opportunity for occasional remote work may be available. 

 

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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