Quality Control Specialist 1
- Ensures that completed lot history records submitted for lot release review are secured prior to disposition. Responsible for timely completion of final product shipping authorization documentation.
- Maintain and file the lot history records and release activities documentation.
- Conducts Data and documentation review and analysis.
- Maintains receiving inspection, work in process and finished product DHR records, procedures, and specifications. Review lot history folders for final lot release sign off and files them in the appropriate location.
- Review a database with all yarn and chemical re-test dates required by the specification.
- Assist in writing inspection and test procedures and other documents relevant to incoming/receiving inspection, work in process, finished product and Lot Release.
- Assists in-house calibrations. Maintains calibration log and coordinate calibration of the respective gauges and equipment.
- Assist in the environmental monitoring reviews.
- Support the Quality Systems such as: Audits, CAPA and preparation of the Management Review deck.
- Perform and maintain SCAR's and MRN's.
- Assist Quality Manager/Quality Engineer in data collection, review, analysis and reports as necessary (related to re-works, sorting, lot release, inspection process time studies and etc.).
- Associates degree in sciences or related discipline or High School diploma and minimum 4 years of relevant Quality experience required
- Two or more years of experience working in a medical device or other regulated industry
- Must have ability to read, write, interpret, comprehend, and consistently follow specifications written in English
- Must have strong attention to detail
- Ability to manage multiple priorities and tasks in a dynamic environment
- Ability to work in a team environment
- Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required
- Good oral and written communication skills.
- Ability to coordinate work cross functionally.
- Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)