What are the responsibilities and job description for the Quality Specialist position at Evergen?
Location: Alachua, FL
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.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;
RESPONSIBILITIES
- Supports quality system compliance with the appropriate internal and external regulatory requirements and maintains awareness of the overall regulatory landscape
- Collects, analyzes, and reports data elements to demonstrate conformity and maintains the effectiveness of the quality management system with a high degree of accuracy
- Contributes to the company process improvement initiatives that impact quality systems and works collaboratively with cross-functional stakeholders to ensure compliance of processes and procedures within the quality management system
- Supports audit and inspection preparation, resolution of audit and inspection findings, and coordinates with auditing groups and inspectors through all stages of the audits
- Applies for and maintains the company’s quality management system licensure including registration and recertification to ensure all licenses stay current
- Acts as a subject matter expert during internal and third-party audits for responsible processes
- Supports all elements of audit planning, execution, closeout, and follow-up with a high level of customer service
- Other duties as assigned
REQUIREMENTS
Education
- Bachelor's Degree
Experience
- 0-3 years of experience in quality assurance, systems, regulatory affairs, or other relevant experience within a regulated industry such as tissue, medical device, or pharmaceutical
- Additional experience may substitute for education requirement
Certification
- Lead Auditor Certification
Skills
- Excellent verbal and written communication
- Microsoft Office Suite
- Quality Management System (QMS) software
- Presentation
- Auditing
Travel
- N/A
SAFETY
Physical Requirement
- 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.)
Working Environment
- Onsite: Office environment with assigned workstation
- Remote positions only: Home office environment with minimum distractions
More about Evergen:
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.
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Salary : $55,000 - $65,000