Quality Assurance Compliance Specialist/ Clarence, NY/1st and 2nd Shifts
An established and growing Clarence, NY Manufacturer is looking for a Quality Assurance Compliance Specialist to support Quality Assurance activities at the facility!
1st shift 7AM-3:30PM
2nd shift (2:00p-10:30p) with initial training on 1st shift (7-3:30 Monday thru Friday with occasional Saturdays possible.
- Performing Acceptable Quality Limits (AQL) inspections during daily manufacturing and labeling processes in accordance with cGMPs and internal procedures
- Providing compliance review of general quality system elements (e.g., change control, work orders, working documents, logbooks)
- Overseeing that processes are in cGMP compliance and establish systems that identify opportunities for continuous improvement
- Supporting Discrepancy Investigations, Corrective and Preventive Actions (CAPA), Effectiveness
- Checks, Internal Auditing and Complaints
- Initiating or executing Action Plan requirements as needed to address investigation or compliance related activities
- Participating in investigations as needed to address problems and assist in resolution
- Completing gowning qualification and maintaining status for entry into Aseptic processing area
- Working closely with manufacturing personnel to meet the needs of operations
- Ensuring good manufacturing and documentation practices
- Knowledge of GMPs, documentation processes/requirements
- Minimum of a high school diploma; Associate degree from accredited college/university preferred
- Minimum of 2 to 5 years of related experience in a regulated environment
- Knowledge of current office software (e.g., Microsoft Word, Excel, Outlook, etc.)
- Experience in electronic control systems (e.g., Mastercontrol)
- Good verbal and written communication skills
Great opportunity with an established and rapidly growing Clarence Manufacturer! Apply today!
Military Veterans encouraged to apply!