Quality Technician

Job DetailsLevel: ExperiencedJob Location: Liquid and Topicals Division MD - Easton, MD 21601Position Type: Full TimeEducation Level: High SchoolSalary Range: $18.00 - $22.00 HourlyTravel Percentage: NoneJob Shift: AnyJob Category: QA - Quality ControlCome join our growing team at Aphena Pharma Solutions !!! Essential Duties and QualificationsEssential 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.