Quality Analyst, Computer Systems Validation
POSITION OBJECTIVE: The Quality Analyst, CSV will be a key leader in the development, maintenance and qualification of Quality Management Systems, Laboratory Management Systems (LMS), Manufacturing Systems, and other computerized systems at Athenex. The Quality Analyst, CSV will help ensure that the solutions/systems are developed to meet departmental needs, and that initial validations, periodic re-validation and change management actions meet 21 CFR Part 11: Electronic Records and Electronic Signatures and 21 CFR Part 210 and 211. The analyst will support system administrative duties, including user management, troubleshooting and problem solving for computerized systems in a timely fashion.
Essential Job Functions/Responsibilities
- Support initial validations and re-validation activities following for Lab/Analytical, Manufacturing and Global 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.
- Perform system administrative duties for managed systems, including documenting and maintaining user accounts, inspection of audit trails, setting up and maintaining environment configuration, work records for periodic re-validation, and change management activities per Athenex polices.
- Support managed software programs including site and cloud hosted applications such as: QAD (ERP software); MasterControl (QMS software); Waters Empower (Chromatography instrument control and data management software) and NuGenesis (LMS, SDMS, and stability management software); Blue Mountain Regulatory Asset Manager (calibration and maintenance management software).
- Work closely with QC, 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.
- Assist in maintaining, authoring and applying CSV and system-specific policies, procedures and forms, as well as assist in providing virtual or hands-on training for updates/roll-outs as needed.
- Ensure timely completion of the required validation, work order, documentation and troubleshooting activities to optimize availability of computerized system software, equipment, and instrumentation for execution of company and customer-directed analytical and/or manufacturing efforts. Includes interfacing with Athenex IT and vendors of software to resolve issues in a timely manner.
- 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 bottlenecks.
- Must have a valid drivers license for travel to local facilities.
- Able to travel locally and nationally for vendor training and/or testing on software systems.
- Other projects as may be assigned.
Required Education & Qualifications
- Minimum B.S. Degree in Chemistry, Engineering or related discipline with minimum 3 years of experience in a chemistry laboratory environment preferred.
- In lieu of a BS degree in related field, minimum 8 years in a quality control or quality assurance environment is required.
- Experience with cGMP 21 CFR 11/210/211/820 Quality Systems required.
- Experience with Change Controls, CAPAs, Deviations, Investigations, Root Cause Analysis, and Risk Assessments desired.
- Excellent interpersonal skills, with direct and positive experience in communicating with Regulatory Authorities, customers, developers and/or executive management preferred.
- Experience with Laboratory Information Management Systems, Enterprise Resource Planning Systems, Computerized Calibration and Maintenance Management Systems, Quality Management Systems, manufacturing process and analytical instrumentation computerized control and data systems.
- Strong analytical and problem-solving skills desired.
- 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.