What are the responsibilities and job description for the Biocompatibility Specialist position at Nelson Labs?
At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of sterility assurance, medical device evaluation services and expert advisory services.
Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays, time-off and the opportunity to attend many company-sponsored employee and family events.
Nelson Labs employees play a critical role in reaching our mission of: Safeguarding Global Health.
Job Summary:
The Biocompatibility Specialist will triage incoming studies to the required Subcontractor and assign them to a Subcontracting Coordinator. They will consult with clients to help them understand the requirements of a test plan for their specific product. This role will partner with the Technical Consulting group to assist with complex client testing projects. The Biocompatibility Specialist will help clients to respond to regulatory agency requests for additional testing, clarifications, etc. They will assist with major Subcontractor Quality Event investigations. This specialist will continually review the scientific literature to keep current with new technical information.
Skills and Education
Required
BS degree (relevant science preferred)
- Knowledge of Biocompatibility and related requirements
- Understanding of In Vivo Testing Process
- Experience in a Vivarium lab setting
Preferred
- Direct consulting experience with the clients (verbal and written communication)
- ISO 10993 experience
Essential Duties:
General
- Triage incoming studies to the required subcontractor and assign to a Subcontracting Coordinator
- Partner with the Sales Department to bring in potential business
- Consult with clients to help them understand the requirements of a test plan for their specific product
- Partner with the Technical Consulting group to assist with complex client testing projects
- Help clients to respond to FDA requests for additional testing, clarifications, etc.
- Assist with major Subcontractor Quality Event investigations
- Participate in ISO10993 discussions
- Continually review the scientific literature to keep current with new technical information
- Act as a trainer and training content developer within the department
- Mentor Subcontracting Coordinators to maintain strong knowledge and enhanced ability to work with clients
- Assist the Subcontracting Leader with the tracking of critical projects
Regulatory Compliance
- Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
- Know and follow company policies and procedures
- Complete required training on time
Professionalism
- Attend work regularly and reliably
- Adhere to all policies and procedures
- Perform other duties as assigned
Competencies of this position
- Understand the ISO 10993 standards
- Attention to detail
- Ability to follow written instructions
- Verbal and written communication skills
- Legible handwriting
- Customer service skills
- Project management skills
- Advanced math skills
- Ability to multi-task
- Computer skills: knowledge of Microsoft Office
- Ability to work independently
Work Environment:
This job operates in a professional office and laboratory environment. This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors, and file cabinets.
Travel requirements:
Occasional travel during the business day. Some out-of-the-area and overnight travel may be expected. May be required to attend trade shows, seminars, and conferences in addition to sales travel.
Physical requirements:
Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer. Must be able to occasionally lift a maximum of 45lbs.
