POSITION OBJECTIVE:   Support Quality Assurance (QA) activities at the Athenex Western New York facilities including: 

  • Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21CFR 210/211.
  • Provides QA support for internal Quality Systems.
  • Ensures that all plant facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them, are effective, efficient, compliant and remain in a state of control. Evaluates and approves Preventative Maintenance, Metrology, Validation and Qualification activities for critical systems and software.
  • Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to resolve problems and provide support on compliance issues and corporate quality policy requirements relating to critical systems.

Support potential CMC and Quality System development of Biologic drug therapies from process development to commercialization launch activities including:

  • Activities to include feasibility and engineering studies, manufacturing process development and scale-up, analytical method development, coordination of Quality Control Stability studies. 
  • Oversight of Contract Manufacturing Organization (CMO) activities where required, to ensure compliance with Athenex and regulatory requirements.

Essential Job Functions/Responsibilities

  • Generation, review, and revision of controlled documents in support of operations, studies, and technical transfers including but not limited to specifications, protocols and standard operating procedures (SOP).
  • Thoroughly investigate process deviations, non-conformances, and other similar Quality Events. Collect information from all necessary internal and external sources to assist in a thorough investigation
  • Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, GAMP, ISO etc.
  • Track and identify trends related to quality deficiencies captured during the investigative process in a proactive manner, and alerting management to concerns
  • Maintain readiness for internal and external audits; support of regulatory body audits, which may include temporary worktimes outside of normal business hours. Conducts internal audits of critical systems, processes and equipment, as well as the quality processes that oversee them, and identify gaps in compliance and opportunities for improvement.
  • Prepares and/or provides review and guidance for regulatory filings, process descriptions, process reports, and change requests.
  • Provide technical oversight and assistance to ensure corrective actions and preventative actions are completed in a timely manner.
  • Monitors product development performance as it relates to relevant quality indicators through appropriate statistical methods.
  • Revise and update SOPs and procedures as a result of investigations / corrective actions.
  • Aid area management to aid in problem solving for critical issues.
  • Assist in management of controls (MOC) for critical equipment and controlled areas, including initiation, execution, and where appropriate, preapproval and final approval of changes.
  • Provides quality oversight for computer system validation, equipment qualification, and facility commissioning and validation. Drafts, and reviews validation documentation for critical systems and equipment.
  • Assist in the development of technology transfer for commercialization of proprietary, generic, and biologic drug products.
  • Troubleshoots problems related to direct impact systems, equipment, instrumentation, and processes, including computerized systems. Analyzes data and implements both corrective and preventative actions to enhance processes.
  • Proactively takes ownership of quality processes and implements solutions in support of continuous improvement.
  • Provides support during operational run times as well as during maintenance shutdown activities both of which may include off shift coverage.
  • Works with Engineering & Maintenance to identify possible trends in facility management systems and impact.
  • Prioritizes and efficiently completes tasks with minimal supervision and consistently delivers on commitments by date requested.
  • Independently and proactively seeks new information to assure compliance through evaluation of available documentation, e.g. other company's 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, ISPE etc.
  • Provides guidance and oversees implementation of regulatory programs.
  • Build and maintain collaborative working relationships within the organization, including effective communication throughout all facets of the organization.
  • Support Quality Management System continuous improvement initiatives.
  • Support other activities/tasks as dictated by departmental and organizational needs.
  • Must have a valid drivers license for travel to local sites and facilities. 
  • Other projects as may be assigned.

Required Education & Qualifications

  • B.S. degree in a technical science or engineering field is required.
  • Minimum of 5 years of quality engineering or related experience, including a working knowledge of GMPs, preferably in commercial pharmaceutical or medical device manufacturing environment.
  • Experience with vaccine production, cell therapy, and or viral vector production, process development, or testing is desired.
  • Experience with facility commissioning is desired.
  • Ability to write reports with excellent attention to detail and planning. 
  • Proven ability to manage multiple tasks, prepare metrics and meet deadlines.
  • Proficiency with current software applications, such as, Office (e.g., Word, Excel, PowerPoint, etc.) is required and proficiency in statistical software applications is preferred.
  • Knowledge and experience with electronic quality management systems preferred.
  • Must be available for off hour and weekend hours for projects as needed.
  • Must have a valid drivers license for travel to local sites and facilities.  

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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