2nd Shift Quality Technician

2nd Shift Quality Technician

Hot Job

Liquid and Topicals Division MD - Easton, MD 21601

Come join our growing team at Aphena Pharma Solutions!!!

Essential Duties and Qualifications

Essential Functions

• Inspect incoming components, in-process product, and finished product according to documented specifications.
• Review all documents prior to the start of production and complete first piece approval (FPA) as required.
• Record data and maintain accurate records in accordance with GMP good documentation practices
• Prepare inspection sheets and other needed forms using Microsoft Word or Microsoft Excel.
• Troubleshoot quality concerns that may arise on the production floor
• Review all paperwork, including device/drug history records (DHR), daily for accuracy and completeness
• Verify the calibration of all inspection test equipment and maintain accurate records.
• Gather data and investigate relative to customer complaints.
• Participate in the execution and documentation of process validations
• Assist in maintaining the quality management system to be in compliance with the current ISO standard and applicable FDA GMP Regulations.
• Perform data entry and retrieval using the Aphena computer system
• May be required, as needed, to work overtime, weekends or alternate shifts.
• Perform pre-approval inspections and maintain accurate records.
• 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.
• Generate controlled labels as needed using programs provided. Document same using proper approval forms and paperwork to issue and return materials from the Label Control Area.
• If necessary, initiate non-conforming or process discrepancy documentation including data entry and labeling requirements. Also responsible for stock segregation if necessary.
• Assist in material flows required to maintain label control operations including consolidation, relocation, and other practices.
• Maintain work area orderliness and cleanliness.
• Inspect incoming, in-process and finished product.

Qualifications

• High school graduate required.
• Advanced college level courses, preferred.
• Previous experience working with GMP Regulations pertaining to medical devices or pharmaceuticals.
• Superior written and verbal communication skills required to communicate issues and procedures among multiple departments.
• Competent with Microsoft Excel, Word and the Internet.
• Ability to solve complex, multi-layered problems.