POSITION OBJECTIVE: Provide quality, and timely support to laboratory management systems for Quality Control department’s needs. This support would include user management, development, troubleshooting and problem solving for computerized systems. 

Essential Job Functions/Responsibilities

  • Provide validation and daily support following Good Manufacturing and Good Laboratory Practices meeting 21 CFR Part 11: Electronic records and Electronic Signatures and 21 CFR Part 210 and 211; GAMP 5 and USP AIQ principles .
  • Function as the lead in validations activities in conjunction with the Validation department for Lab/Analytical computerized systems (software, hardware, instrumentation, and network support), including authoring, and executing Risk Assessments, Requirement Specifications (URS/FRS), Protocols (IQ/OQ/PQ), change controls, and all documentation relevant to the projects.
  • Dedicated resource for the QC department, reporting to QA, applying QA/CSV principles and procedures to ensure the operation, performance, maintenance and availability of lab systems to the QC department.
  • Support laboratory software programs including site and cloud hosted applications such as: Waters Empower (Chromatography instrument control and data management software) and NuGenesis (LMS, SDMS, and stability management software); as well as other managed software programs in the laboratory setting. This management includes supporting multiple users across various Athenex sites (Clarence, Dunkirk and Buffalo).
  • Works closely and acts as a liaison between Quality Engineering, Metrology, Information Technology, other facility departments and vendors to ensure compliance with GMP and Athenex SOPs for equipment, processes, and systems as they pertain to computerized data systems in the laboratory.
  • Administrate, maintain and troubleshoot instrumentation and computerized systems dedicated to the laboratories on a daily basis, managing change control and investigation methods per internal processes as needed.
  • Assist in maintaining, authoring, and applying laboratory system-specific policies, procedures, and forms, as well as assist in providing virtual or hands-on training for updates/rollouts as needed.
  • Perform risk assessments on patient safety and data integrity on electronic systems that are deviant from trend or acceptance criteria, applying knowledge of cGMP, FDA 21 CFR Part 11, Root Cause Analysis (RCA) and Quality Management System (QMS) principles to ensure compliance and effective solutions. Includes issues pertaining to audit trail reviews, configuration/access reviews, and backup/restore activities.
  • Support continuous improvement efforts by monitoring system performance and collaborating with system stakeholders, day-to-day users, and vendors to realize updated functionality and workflows to address organizational needs and the downstream impacts of system changes.
  • Must have a valid drivers license for travel between local facilities. 
  • Other projects as may be assigned

Required Education & Qualifications

  • Bachelor of Science degree in an applicable life-science or related discipline with a minimum of 3 years’ experience in a GMP environment preferred or an associate degree in an applicable life science with a minimum of 8 years of experience in quality control or quality assurance environment is required.
  • Experience with Laboratory Information Management Systems, Quality Management Systems, and analytical instrumentation computerized control and data systems.
  • Experience with analytical instrumentation such as, chromatography, dissolution, FTIR, UV-Vis, auto titrators, etc. is preferred.
  • Experience with cGMP 21 CFR 11/210/211/820 Quality Systems, USP Analytical Instrumentation Qualification, and GAMP 5 preferred.
  • Experience with Change Controls, CAPAs, Deviations, Investigations, Root Cause Analysis, and Risk Assessments desired.
  • Excellent verbal and written communication skills and able to effectively communicate to multiple levels within the organization, business teams and vendors.
  • Solid technical background with analytical and problem-solving skills desired.
  • Ability to work with short project cycles and capable of handling and prioritizing multiple tasks.
  • Proficiency with Microsoft Office Suite or related software desired.
  • Must have a valid drivers license for travel between local 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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