Senior Microbiologist.US-PBF.002

3 days left

Employer
Integra LifeSciences
Location
Plainsboro, New Jersey, US
Salary
Competitive
Posted
Jul 03, 2021
Closes
Jul 31, 2021
Ref
2279728763
Discipline
Other
Employment Type
Full time
Salary Type
Salary
Overview:
Integra LifeSciencesis 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, weve evolved into one of the worlds leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But thats just the beginning.Integra is growing at an unprecedented rate. Were at a moment in time where the experience youll gain is more robust than the experience you bring. And were out to invest in your future because its 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 Integras ongoing commitment to our values and our shared success.Integras 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 employees short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

Responsibilities:
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 laboratory notebooks and 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 in order 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 in the Microbiology departmentInteract 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.

Qualifications:
Bachelors degree, in Microbiology or Biology preferred5+ years of relevant GMP/GLP laboratory experience in regulated industry. Capable of both written and verbal effective communications skills including presentations Demonstrate organizational and time management skillsMust be able to work independently with minimal supervisionKnowledge of MS Office Suite

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