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Microbiologist II

  • Anywhere

Company :
Integra LifeSciences Corporation

Location :
Plainsboro, New Jersey

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol IART.RESPONSIBILITIES Responsibilities The Microbiologist II will provide support to the QC Microbiology Laboratory by performing functions such as laboratory testing for in-process and finished good medical devices, environmental monitoring of cleanrooms, data analysis, laboratory investigations, test method development, and process improvement projects. This position is responsible for ensuring microbiological control of medical device products in compliance with all applicable corporate and regulatory policies. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: 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.QUALIFICATIONS What are we looking for? Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. 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 While undertaking the essential duties and responsibilities of the position, the employee must repeatedly speak and write in English. The employee is required to go to all areas of the company, including the manufacturing cleanrooms. The employee may be required to periodically lift and/or move up to 25lbs. OUR PRODUCTS We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world. OUR CULTURE We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas – big and small – are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company. OUR VALUES We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you’d like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at or call us at . 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