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Supervisor, Microbiology

  • Anywhere

Company :
Integra LifeSciences Corporation

Location :
Plainsboro, New Jersey

Expiry Date :
Sun, 06 Dec 2020 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 Microbiology Supervisor provides technical and supervisory leadership and mentoring to Microbiology group members and provides support to management. Directs, coordinates, and evaluates the activities of associates in the Microbiology Lab, including laboratory testing for in-process and finished good products, environmental monitoring, validation studies, and adherence to all applicable regulations, policies, and procedures. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Responsible for supervising all Microbiology Laboratory personnel and operations, including product testing, environmental monitoring of cleanrooms, cleanroom gowning qualifications, utility testing (WFI, pure steam, clean compressed air), lab supply purchasing, and laboratory projects. Responsible for reviewing and approving laboratory work and issuing Certificates of Analysis for product lots. Assigns duties and responsibilities to subordinate laboratory staff, including benchwork, laboratory maintenance activities, laboratory projects, data review, and data entry. Coordinates production activities with Operations teams and schedules Microbiologists to support these activities across 1st and 2nd shifts. Manages cleanroom gowning qualification for all plant personnel. Coordinates with other departments to schedule personnel for qualification. Coordinates all microbiological testing performed at external laboratories. Interacts with suppliers and customers as needed. Maintains GMP/GLP laboratory logbooks and documentation relevant to the duties and responsibilities assigned. Develops laboratory test methods and oversees test method validations and implementation. Provides support as needed for other validations that involve microbiological testing, including EMPQs and utility qualifications. Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits. Performs Out of Specification (OOS) investigations, Non-Conformance (NC) investigations, and Corrective Action / Preventative Actions (CAPA). Prepares and/or reviews trending reports for quality control testing, environmental monitoring, and other laboratory testing as required. Provides staff with leadership, support, and mentoring. Conducts performance reviews for lab personnel, holds regular team meetings, and provides training to junior staff as needed.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 or higher in Microbiology, Biology, or related field. 5-7 years of relevant GMP/GLP laboratory experience in regulated industry, with supervisory and project leadership experience. Must have method development, validation, and transfer experience in the pharma or medical device industry. Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings. Knowledge of MS Office Suite 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. 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