Quality Assurance (QA) activities at the Athenex Western New York sites with a focus on Dunkirk, NY facility start up and tech transfer. Activities to include issuance and review of regulated documents, ensure processes and products are in compliance with current Good Manufacturing Practices and 21CFR 210/211, and provide QA support for internal Quality Systems. Responsible for ensuring 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. Responsible for evaluating for compliance and approval of Preventative Maintenance, Metrology, Validation and Qualification activities for all critical systems and software. Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to solve problems and provide support on compliance issues and corporate quality policy requirements relating to critical systems.
This position will be located in the Buffalo, NY office until the Dunkirk facility obtains occupancy which the position will then move permanently to that facility.
Essential Job Functions/Responsibilities
- Generation of controlled documents in support of operations, studies, and tech transfers including but not limited to specifications, protocols and standard operating procedures.
- 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 all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
- Track and identify trends related to quality deficiencies captured during the investigative process being proactive alerting management to concerns
- Maintain department readiness for internal and external audits
- Provide technical oversight and assistance to ensure corrective actions and preventative actions are complete and timely.
- Revise and update SOP’s and procedures as a result of investigations / corrective actions
- Provide assistance to area management to aid in problem solving for critical issues.
- Provide compliance review of general quality system elements (e.g., change control, work orders, working documents, etc.)
- Assist in management of controls (MOC) for critical equipment and controlled areas which include preapproval and post approval of change controls.
- 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 and generic drug products.
- Troubleshoots problems related to critical systems and equipment, 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 during installation of new processes, software, or equipment.
- Works with Engineering & Maintenance to identify possible trends in facility management systems and impact.
- Develops, red-lines, reviews, and/or implements quality documents related to critical systems, processes and equipment.
- Conducts internal audits of all critical systems, processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement.
- 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
- Monitors Product Development performance as it relates to relevant quality indicators through appropriate statistical methods.
- Prepares and/or provides review and guidance for regulatory filings, process descriptions, process reports and change requests.
- Build and maintain collaborative working relationships within the organization, including effective communication throughout all facets of the organization
- Support QA compliance activities as needed, including support of regulatory body audits, which may include temporary worktimes outside of normal business hours.
- Support Quality Management System continual improvement initiatives
- Other activities/tasks as dictated by departmental and organizational needs
Required Education & Qualifications
- B.S. degree in a technical science or engineering field is required.
- Minimum of 2-3 years of quality engineering or related experience, including a working knowledge of GMPs, preferably in commercial pharmaceutical or medical device manufacturing environment.
- Experience with facility expansion/commissioning is desired.
- Proven ability to manage multiple tasks, prepare metrics and meet deadlines.
- Knowledge & experience with use of current software MSOffice (e.g., Word, Excel, PowerPoint, etc.)
- Knowledge and experience with use of electronic quality management systems 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.