Sr. Manufacturing Records Associate

Evergen•Alachua, FL

2d•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. Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.

Requirements

High school diploma or equivalent
4-6 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.)
Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions

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
Makes sound decisions with limited supervision; prioritizes and manages time efficiently
Monitors and coordinates specialized graft processing steps from point of receipt through finished goods and distribution
Communicates with operations, quality, and sales on the status and availability of specialized grafts
Participates in investigations and corrective actions pertaining to receipt, manufacturing, and release of specialized grafts
Applies critical decision-making on acceptance or rejection of specialist graft records
Leads training for new employees and mentors team
Other duties as assigned