- Job Level:
Perform review of completed quality documents/records for the release of raw materials and components for production and finished goods for sale/distribution.
- Batch Records (Pre and Final Review)
- Incoming Inspection Records
- Initiate Quality Issues/Events reporting (Nonconformance, Customer Complaints, CAPA) and assist QA/QC Management in the timely investigation, handling, and completion of these Quality Issues/Events.
- Assist with all Document Control activities – such as document creation/revision and filing of quality documents
- Assist in the implementation of site product and process changes through established change control process.
- Perform QC-related inspections (Incoming, In-Process and Final Product Inspections (involves mostly visual type inspection with some laboratory testing utilizing basic lab equipment including pH meter and micro pipette)
- Verify product labeling and shipment documentation for completeness and accuracy
- Assist with implementation of Quality System improvements/changes
- Other duties as assigned by Quality Management
Minimum of Bachelor’s degree in a technical field preferred. 2 year degree in technical field acceptable.
Experience & Skills Required
- Experience in either medical device or pharmaceutical industry preferred.
- Working knowledge of Microsoft Word and Excel
- Work within a team as well as work independently
- Strong attention to detail and integrity