What are the responsibilities and job description for the QC Specialist position at System One Holdings, LLC?
Job Title : QC Specialist
Location : Jersey City, NJ
Type : Direct Hire
Hours : Monday-Friday 9AM-5PM
Job Summary :
Our company is recognized as a certified global leader in medical biotechnologies, specializing in cellular therapies. We are looking for a talented and competitive QC specialist who thrives in the medical device manufacturing industry.
The Quality Control Officer is responsible for maintaining quality control processes, analyzing the results, and giving feedback and guidance to the production team under direct supervision. Ensures and assists in determining if materials, products, and / or processes are in accordance with specifications and ensures the staff follows the set processes and adheres to best production practices and product quality standards.
Responsibilities :
- Approve incoming materials by confirming specifications, conducting a visual and measurement test, and rejecting and returning unacceptable materials.
- Approve in-process production by confirming required specifications, conducting visual and measurement tests, and communicating the required adjustments to the production supervisor.
- Document and update inspection results by completing reports and logs.
- Perform QC testing including LAL testing for manufacturing and validation processes.
- Verify all finished products by confirming specifications and conducting required tests.
- Verify and Approve Sterilization Processing Certificate.
- Return products for re-work if needed and complete documentation to confirm re-work.
- Keep measuring equipment operating by following operating instructions and calling for repairs (calibration plan and records management).
- Maintaining the quality of the laboratory environment including the clean room, laboratory, and QC laboratory (Environmental Control SOP).
- Performs Quarterly low-dose audit and drafting of the final report.
- Plans the scheduling of biocontamination services.
- Assist in validation of methods.
- Other duties as assigned by the Global Chief Operations Officer or QA / RA Manager
Requirements :
