Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.
Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.
But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.
Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.
Considered a subject matter expert (SME) for test method(s) executed in the laboratory.
Perform and document in-house microbiological testing on all in-process and finished products to comply with acceptance requirements.
Perform endotoxin (LAL) testing, Bioburden analysis, growth promotion, gram staining, identification of microorganisms, and other microbiological testing.
Perform and document environmental monitoring of cleanrooms, including non-viable particulate, active viable airborne, and viable surface contact sampling.
Sample utility systems including WFI, steam, and compressed air.
Provide gowning training and qualification to operators, cleaners, and other essential staff.
Manage sample shipment and processing with third party labs.
Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
Maintain laboratory instrumentation and report any equipment issues to Supervisor.
Complete laboratory Alert/Action (AA) notifications and Out-of-Specification (OOS) investigations.
May be responsible for representing the department in cross functional meetings.
Assist in the review of test data and report any deviations to Supervisor.
Train and provide guidance to team members in the Microbiology department.
Analyze trend data and create trending reports.
Create/Revise Standard Operating Procedures (SOPs).
Responsible for writing investigations in order to identify root causes and recommend corrective actions to support and improve production. Drive assigned CAPAs to closure.
Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
Perform other related duties as required.
Bachelor's degree, in Microbiology or Biology preferred
3+ years of relevant GMP/GLP laboratory experience in regulated industry.
Demonstrate effective written and verbal communication skills
Must be able to work independently with minimal supervision
Demonstrate organizational and time management skills
Knowledge of MS Office Suite