Integra LifeSciences Senior Chemist in Plainsboro, New Jersey
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.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Responsible for working with operations and other cross functional team members, which requires proactive inter and intra departmental communication, flexibility, and tact.Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives.
Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.
Participate in projects involving the Quality Control departments, including new method/equipment validations.
Considered a subject matter expert (SME) for test method(s) executed in the laboratory
Oversee and/or perform instrumental (i.e., UV-Vis, HPLC) and wet chemistry techniques/analyses.
Oversee and/or perform laboratory testing, as well as general laboratory maintenance, including in process and final product release testing and stability testing.
Review test data and logbooks, report any deviations to the Supervisor
Ensure timely testing and result reporting
Manage sample/testing 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 the Supervisor
Assist as needed in test method validation, implementation, and execution.
Assist in preparing for and participating in FDA audits, customer audits, etc.
Complete Out of Specification (OOS) Investigations, Non-conformance Investigations (NCs), Quality Investigations (QIs), and Corrective Action/ Preventative Actions (CAPAs)
Create/Revise Standard Operating Procedures (SOPs)
Complete trending reports for In-process and Finished Goods Quality Control Testing, as well as Stability Testing.
Demonstrate excellent organizational and time management skills.
Review test data and report any deviations to supervisor.
Provide guidance and mentoring to junior lab members.
Design experimental plans to address specific laboratory issues as needed.
Perform other related duties as required.
Bachelor’s Degree in chemistry, or biological sciences, preferred
Advance Degree preferred
10+ years of related experience
Working knowledge of standard laboratory practices and safety
Must be able to work independently with minimal supervision
Capable of both written and verbal effective communication skills
Experience with Microsoft Office to create reports, spreadsheets, trend data and create presentations
Vacancy ID 2018-26449
Position Type Regular Full-Time
Category Quality Assurance