Product Release Coordinator I

Bausch + Lomb•US-SC-Greenville, SC

8h•Onsite

About The Position

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. This role involves auditing Lot History Records for finished product release, acting as a liaison between QAPC and Manufacturing for document discrepancies, supporting investigations, and initiating lot segregations and rejections. Additionally, the role manages Lot Master Maintenance for distributed products using BPCS and Peoplesoft, controlling lot disposition and reconciling inventory before distribution. The position also involves initiating notifications for SOP reviews, issuing SOP status reminders, and completing monthly reports. Support for regulatory audits (FDA, ISO, Customer) is also a key responsibility, which may include retrieving records, executing queries, and assisting as a scribe or runner.

Requirements

High School Diploma/ GED required.
Demonstrated proficiency in Microsoft Office to include use of Excel spreadsheets, Microsoft Word, and ACCESS database.
Demonstrated proficiency in the use of email.
Must be authorized to work for ANY employer in the U.S.

Nice To Haves

Well organized with the ability to multi-task and shift priorities as needed to meet customer demands.
Knowledge and experience with the Visio program is preferred.

Responsibilities

Complete the audit and release of all Lot History Records associated with finished product release in a timely manner.
Audit Sterilization Cycles (Steam, Gamma Irradiation, Ethylene Oxide exposure).
Audit Solution Manufacturing (Batch Records from Upper Mix, Lower Mix, Filling, Packaging, and QA).
Audit Accessory Manufacturing (Packaging and QA).
Audit Contract Finished Goods (as described per local procedure).
Act as a liaison between QAPC and Manufacturing to notify them of any document discrepancies discovered during the LHR audit.
Support any investigations by providing Lot History Records and/or process knowledge.
Initiate Lot segregations and rejections as necessary (physical and systematic verification).
Control the Lot Master Maintenance for all (Lot Controlled) distributed product using BPCS and Peoplesoft.
Control the final disposition of product Lots and reconcile inventory of those lots within the systems (BPCS, Peoplesoft and/or Optum) prior to initiating the distribution thereof.
Initiate notifications of SOPs to be reviewed, issuing periodic SOP status reminders, and completing monthly reports.
Support the Quality group during external audits (FDA, ISO, and Customer) by retrieving filed/archived records, executing queries, and/or acting as a scribe or runner.