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. At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success. Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both. Regardless of geographic location, our commitment is to offer the following, whenever possible:Benefit plans that meet all local statutory requirementsA range of programs that reflect typical local market practicesAn opportunity for employees to tailor benefits to their specific needsBenefits that balance employee's short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program
This position shall lead key QA/Compliance activities in the following areas as assigned by the Sr. Manager, Quality Engineering:Ensure Product Monitoring Testing and Analysis, Surveillance Trend Reporting, and Monitoring Metrics are conducted and documented in accordance to internal and external requirements.Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.Perform and document in-house microbiological testing on all in-process and finished products to comply with acceptance requirements. Perform LAL, water analysis, growth promotion, gram staining, identification of microorganisms and other microbiological testingSubmit samples for shipment to third party labs when necessaryManage sample/testing processing with third party labs, ensure timely testing and result reporting.Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.Maintain laboratory instrumentation required for testing.Assist with proper execution of laboratory Alert/Action (AA) and Out-of-Specification (OOS) investigations. Review AA and OOS investigations as needed. Responsible for working with operations and other cross functional team members, which requires proactive inter- and intra- departmental communication, flexibility, and tact.Responsible for writing investigations to identify root causes and recommend corrective actions to support and improve production. Drive assigned CAPA to closure.Review test data and report any deviations to supervisor. Provide guidance and mentoring to junior lab members. Train team members on various aspects of microbiology. Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives.Design experimental plans to address specific laboratory issues as needed. Analyze trend data and create trending reports. Update and/or create Standard Operating Procedures (SOPs) as needed.Participate in projects involving the Quality Control and/or Microbiology departments, including new method/equipment validations.Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.Perform other related duties as required. NOTE: Senior Microbiologist is expected to serve as Subject Matter Expert and lead activities relating to Microbiology.
Bachelor's, or preferably Master of Science degree, in Microbiology or similar discipline.5-7 years' experience in Microbiology in Life Sciences Industry, preferably Medical Device Industry.Expert knowledge in Good Laboratory Practices.Scientific Expertise in the area of Microbiology theory and application, including general lab techniques and testing.Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).Working knowledge of Microbiology related QMS elements including Product Monitoring Tests and Surveillance Reporting, Cleanroom Controls, Environmental Monitoring and Contamination Controls.Working knowledge of medical device regulations (including FDA QSRs, ISO13485).Working knowledge of CAPA processes including investigational techniques.Working Knowledge of Risk Management regulations and application (ISO14971).Ability to communicate effectively (both written and oral) using English (or local language).Demonstrated ability to work cross-functionally in a team environment.Ability to work independently with little supervision.Proficient with the MS Office Suite. Some experience with Minitab and similar toolsMust be able to observe company policies and safety procedures at all times.In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.