Product Release Coordinator I

Product Release Coordinator I Purpose of Job: The Product Release Coordinator I position is responsible for completing the audit and release of Lot History Records for sterilized components, packaged solutions, accessories, and contract finished goods. Key Activities: AUDITING and PRODUCT RELEASE The audit and release of all Lot History Records associated with finished product release must be completed in a timely manner. These records consist of the following: Sterilization Cycles (conducted by Steam, Gamma Irradiation, and Ethylene Oxide exposure) Solution Manufacturing (Batch Records from Upper Mix, Lower Mix, Filling, Packaging, and QA) Accessory Manufacturing (Packaging and QA) Contract Finished Goods (as described per local procedure) In conjunction with auditing, the Release Coordinator I acts as a liaison between QAPC and Manufacturing to notify them of any document discrepancies discovered during the LHR audit. Likewise, the RC is required to support any investigations by providing Lot History Records and/or process knowledge. In addition to product release, the Product Release Coordinator I is also required to initiate Lot segregations and rejections as necessary (physical and systematic verification).

LOT STATUS CONTROL THROUGH SYSTEM TRANSACTIONS

The Product Release Coordinator I controls the Lot Master Maintenance for all (Lot Controlled) distributed product using BPCS and Peoplesoft. Through these transactions, the RC carries the responsibility of controlling the final disposition of product Lots, and reconciling inventory of those lots within the systems (BPCS, Peoplesoft and/or Optum) prior to initiating the distribution thereof. Notifications of SOPs to be reviewed, issuing periodic SOP status reminders, completing monthly reports.

REGULATORY AUDIT SUPPORT

As required, the Product Release Coordinator I will support the Quality group during external audits (FDA, ISO, and Customer). During the audit, the RC may be asked to retrieve filed/archived records, execute queries, and/or act as a scribe or runner. Qualifications: Education: High School Diploma/ GED required. Preferred Skills: Well organized with the ability to multi-task and shift priorities as needed to meet customer demands. Demonstrated proficiency in Microsoft Office to include use of Excel spreadsheets, Microsoft Word, and ACCESS database. Knowledge and experience with the Visio program is preferred. Demonstrated proficiency in the use of email. Location: Greenville, SC. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr Bausch + Lomb