Senior Quality Technician

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

•    Provides support for Quality Engineering functions such as manufacturing, sterility assurance, or supplier quality and may lead projects and improvement initiatives

•    Leads investigations for product or supplier nonconformance and process noncompliance issues and documents exceptions appropriately in the Corrective Action / Preventative Action (CAPA) System

•    Performs CAPA activities inclusive of root cause analysis, investigations, product and process disposition, and effectiveness check with a high attention to detail

•    Participates in the review and disposition of non-conforming product or controlled process inputs including the Product Quality Review Board (PQRB), returns, and complaints

•    Supports validation activities inclusive of reviewing and approving data sheets, drafting of validation protocols, and documenting the results in a validation report

•    Performs process and safety audits and documents the results appropriately

•    Assists in Change Management function including maintaining relevant Work Instructions,

•    Standard Operating Procedures, and other documentation

•    Performs product acceptance testing, quality inspections, data entry, and data corrections quickly and accurately

•    May provide support for environmental monitoring investigations, documentation of quality inspections on controlled suppliers, or supports the Approved Supplier List monitoring activities

•    Identifies and supports process improvement initiatives and implementation

•    May support projects as a quality resource as assigned

•    May mentor or train other team members

REQUIREMENTS

Education

High School diploma or equivalent

Experience

•    6 years of experience in quality assurance or quality control

•    Additional education may substitute for experience requirement

•    Experience in Microbiology or Biology preferred 

Certification

ASQ certification preferred

SKILLS

•    Strong verbal and written communication

•    Microsoft Office Suite, basic Excel

•    Technical Writing

•    Investigations

•    Problem-solving methodologies

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