2nd Shift Quality Assurance Technician
About The Position
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. Qualifications• 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.
Requirements
- Knowledge of Current Good Manufacturing Practice cGMP) Regulations pertaining to medical devices and pharmaceuticals.
- Ability to work With Microsoft Excel, Word, and PowerPoint.
Responsibilities
- 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
- 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.
- 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.
- Serve as backup for QA Technician when needed.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
