As a QA Compliance Specialist (AQL), you will support Quality Assurance activities at the Athenex Pharma Solutions Clarence, NY facility. Activities to include inspections of manufacturing and labeling processes for in-process and finished goods, ensure processes and products are in compliance with current Good Manufacturing Practices and 21CFR210/21, and provide QA support for internal Quality Systems.
This is a first shift position. Hours are 7 AM to 3:30 PM, Monday through Friday. Start and end times may shift due to needs of production support.
Essential Job Functions/Responsibilities
- Performs AQL (Acceptable Quality Limits) inspections during daily manufacturing and labeling processes in accordance with cGMPs and internal procedures
- Provides compliance review of general quality system elements (e.g., change control, work orders, working documents, logbooks)
- Oversees that processes are in cGMP Compliance and establish systems that identify opportunities for continuous improvement
- Supports Discrepancy Investigations, Corrective and Preventive Actions (CAPA), Effectiveness Checks, Internal Auditing and Complaints
- Initiates or executes Action Plan requirements as needed to address investigation or compliance related activities
- Participates in investigations as needed to address problems and assist in resolution
- Completion of gowning qualification and maintaining status for entry into Aseptic processing area
- Works closely with manufacturing personnel to meet the needs of operations
- Ensures good manufacturing and documentation practices
- Other projects as may be assigned.
Required Education & Qualifications
- High school diploma or equivalent required; Associate degree from accredited college/university preferred
- Minimum of 2 to 5 years’ experience in a regulated environment
- Knowledge of GMPs, documentation processes/requirements
- Excellent attention to detail
- Knowledge of current software (e.g., Microsoft Office)
- Experience in electronic control systems (e.g., Mastercontrol)
- Good verbal and written communication skills
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.