2nd Shift Quality Control Technician

Come join our growing team !!!

Qualifications

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.
• Written and verbal communication skills are required to communicate issues and procedures among

multiple departments.