Manufacturing Records Associate 2

Evergen•Alachua, FL

6h•Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ.

Requirements

High School diploma or equivalent
2-5 years of experience working with records or charts in a regulated industry
Strong verbal and written communication
Microsoft Office Suite
Record Management
Data entry software
Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Responsibilities

Receives, sorts, and files documents from manufacturing, biomedical lab, and other sources into the appropriate manufacturing record with a high level of accuracy
Assembles the documents in the manufacturing record, performs a review on documents to ensure traceability, and releases acceptable products
Follows the necessary Standard Operating Procedures and assures compliance with quality system requirements for FDA and other accreditation standards
Applies status for tissue holds and requests additional documentation from other departments to assure completeness of manufacturing records
Pulls, files, prints, and reconciles manufacturing charts to maintain manufacturing records
Exhibits exceptional attention to details to ensure compliance and product safety
Identifies and resolves documentation issues with external departments
Communicates with operations and quality on the status and availability of priority grafts, associated with pending orders, backorders, or low inventory
Assists in training new employees
Makes sound decisions with limited supervision; prioritizes and manages time efficiently
Other duties as assigned