Quality Control Technician – Data-Driven QA (Med Devices)

APHENA PHARMA SOLUTIONS-MARYLAND LLC; Easton (MD); On-site; USD 25,000 - 28,000; Full time

Job summary

Aphena Pharma Solutions-Maryland LLC in Easton, MD is seeking a QA support associate for the Liquid and Topicals Division. This full-time role focuses on inspecting incoming components and maintaining accurate records in line with cGMP, ensuring proper labeling and data entry.

You will help investigate quality concerns, assist CAPA activities, verify equipment calibration, and communicate findings across departments.

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
• 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.

Job description

Aphena Pharma Solutions-Maryland LLC in Easton, MD is seeking a QA support associate for the Liquid and Topicals Division. This full-time role focuses on inspecting incoming components and maintaining accurate records in line with cGMP, ensuring proper labeling and data entry.

You will help investigate quality concerns, assist CAPA activities, verify equipment calibration, and communicate findings across departments.