7 am - 3:30 pm
Summary
The Quality Control (QC) Coordinator is responsible for providing support to the QC analytical and microbiology laboratories through submitting and tracking of samples and paperwork to the laboratory, reviewing and archiving completed testing paperwork and reporting of test results.
Responsibilities include, but are not limited to:
• Provide updates to Management regarding the status of samples undergoing testing in QC.
• Submit samples for outside testing, track testing completion, collect various documents to support product release.
• Creation of Certificate of Analysis (COA’s) to document that products conform to various customer and country specific requirements. Includes establishing relationship with International and Regulatory teams to set priorities and resolve issues.
• Support supervisors with administrative aspects of daily release testing.
• Provide status updates to and attends meeting with other departments (i.e. Global Supplier Quality, Global Analytical Services, Tech Services) regarding the submission of samples, expected completion dates and result reporting.
• Support supervisors with daily test sample assignments to QC Analyst according to the type of incoming samples- Standard QC samples and special samples (stability, R&D, Tech Services, customer complaint, etc.) .
• Communicate (e-mail and phone) with appropriate departments and personnel to help resolve issues and avoid testing delays, such as obtaining missing information such as documentation, requesting additional or missing samples for testing and solving specification issues.
• Creating reports including but not limited to quality data trending, informational spreadsheets, laboratory log spreadsheets, stability spreadsheets, etc.
• Reviews certificates of analysis (COA) from raw material suppliers, contract manufacturers for bulk and turnkey items, QA/QC reports and other quality documents.
• Creates Purchase Orders for QC Department supplies and outside testing needs and manages the receipts and invoices through the iBuy system
• Serves to provide guidance to the Quality Coordinator group regarding training needs, organization of work flow among the team and resolution of problems.
• Adheres to SOP’s, GMP’s and safety requirements