2nd Shift Quality Control Technician
About The Position
The Quality Control Technician will assist with the inspection of incoming components according to documented specifications and generate and approve controlled labels. This role involves recording data and maintaining accurate records in accordance with cGMP, retrieving documents using the EQMS computer system, and troubleshooting quality concerns, reporting them to the Quality Manager. The technician will verify the calibration of inspection test equipment, perform data entry using the Aphena computer system, and may be required to work overtime, weekends, or alternate shifts. Key responsibilities also include assisting in the generation and resolution of corrective and preventive action plans (CAPAs), documenting and resolving nonconforming material reports and process discrepancy reports, and ensuring nonconformances are initiated promptly. The technician will maintain work area orderliness and cleanliness, assist in maintaining compliance within the quality system, and ensure test equipment is maintained and calibrated. Strong written and verbal communication skills are essential for inter-departmental communication and professional interaction with co-workers. The role requires knowledge of cGMP Regulations pertaining to medical devices and pharmaceuticals, managing daily activities to support business operations, ensuring timely and cGMP-compliant paperwork, determining root cause and corrective actions for investigations, CAPAs, and 005 issues, maintaining operational efficiency and compliance of test equipment, providing QA support for new products, performing/assisting in cGMP validations, and reviewing in-process batch records and equipment notebooks daily. Proficiency in Microsoft Excel, Word, and PowerPoint is also required, and the technician will serve as a backup for the QA Technician when needed.
Requirements
- 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.
- Ability to work With Microsoft Excel, Word, and PowerPoint.
Responsibilities
- Assist with the Inspection of incoming components according to documented specifications.
- Assist 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
