2nd Shift Quality Assurance Technician

Core Quality Functions

•  Assist with the Inspection of incoming components according to documented specifications.
•  Asist with the generation and approve controlled labels using programs provided.
•  Record data and maintain accurate records in accordance with cGMP current good documentation 
practices for accuracy and completeness.
•  Retrieval of documents using the EQMS computer system.
•  Troubleshoot quality concerns that may arise during incoming components and report to Quality 
Manager.
•  Verify the calibration of all inspection test equipment and maintain accurate records.

•  Perform data entry and retrieval using the Aphena computer system
•  May be required, as needed, to work overtime, weekends or alternate shifts.
•  Assist in the generation and resolution of corrective and preventive action plans (CAPAs)
•  Assist in the documentation and resolution of nonconforming material reports and process 
discrepancy reports.
•  Ensure nonconformances are initiated and reported promptly.

•  If necessary, initiate non-conforming or process discrepancy documentation
•  Maintain work area orderliness and cleanliness.
•  Assist in maintaining compliance within the quality system.
•  Ensure that the test equipment is maintained and records kept.
•  Ensure equipment is calibrated before use.
•  Written and verbal communication skills are required to communicate issues and procedures among 
multiple departments.
•  Ability to interact with other co-workers at a professional level

•  Job requires data entry [writing] that requires neatness and accurate records.
 

•   Knowledge of Current Good Manufacturing Practice {cGMP) Regulations pertaining to medical 
devices and pharmaceuticals.

•  Manage daily activities to ensure support for business operations.
•  Ensure paperwork is completed within a timing manner and complies with cGMP.
•  Determine root cause and corrective and preventive action plan for any Investigations, CAPA, and 
005 issues related to the area of responsibility and complete related documentation.
•  Maintain operational efficiency and compliance with all test equipment and processes.
•  Provide the necessary QA support needed for the rapid commercialization of new products and 
processes.
•  Perform/assist in any required cGMP validations.
•  Review in process batch records and equipment notebooks daily.
•  Ability to work With Microsoft Excel, Word, and PowerPoint.
•  Serve as backup for QA Technician when needed.
•  Written and verbal communication skills are required to communicate issues and procedures among 
multiple departments.
 

Salary : $18 - $20