What are the responsibilities and job description for the Sr. Manufacturing Records Associate position at Evergen?
Location: Onsite in Alachua, FL
RTI Surgical is now Evergen!
This rebrand reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.
About Evergen:
Evergen (formally RTI Surgical) 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.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM
JOB 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
Education
- High School diploma or equivalent
Experience
- 4-6 years of experience working with records or charts in a regulated industry
Certification
- N/A
Skills
- Strong verbal and written communication
- Microsoft Office Suite
- Record Management
- Data Entry Software
Travel
- N/A
SAFETY
Physical Requirement
- Move or lift objects up to 25 pounds
- Frequent (>75%) stationary position (standing or sitting) while utilizing digital
- Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Working Environment
- Onsite: Office environment with assigned workstation
