Sr Chemist.US-PBF.403

Employer
Integra LifeSciences Holdings Corporation
Location
Plainsboro, NJ
Posted
Jul 23, 2021
Closes
Jul 25, 2021
Ref
2327112331
Sector
Other
Organization Type
Corporate
Overview

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 requirements
  • A range of programs that reflect typical local market practices
  • An opportunity for employees to tailor benefits to their specific needs
  • Benefits that balance employee's short-term and long-term needs

Click HERE for more information regarding our benefits and total rewards program

Responsibilities

The Sr. Chemist will provide support to the QC Analytical Laboratory for the testing of in-process and finished good products, raw materials, water, stability studies, and validation studies. This position requires expertise in the analytical test methods and is responsible for operating in compliance with all applicable procedures, policies, and regulations.

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 analytical test method(s) executed in the laboratory.
  • Perform and document instrumental (e.g., UV-VIS, HPLC, FTIR, Instron) and wet chemistry techniques/analyses.
  • Perform laboratory testing including in-process and final product release testing and stability testing.
  • 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.
  • Participate in projects involving Quality Control which include new test methods or instrumentation.
  • Assist as needed in test method validation, implementation, and execution.
  • Report any equipment and testing deviations to the Supervisor.
  • Complete Out-of-Specification (OOS) investigations as assigned.
  • Complete data entry for trending reports for In-process and Finished Goods Quality Control Testing, as well as Stability Testing.
  • Ensure timely shipment of samples to third-party lab when necessary.
  • 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.
  • Assist in revising Standard Operating Procedures (SOPs).
  • Train and provide guidance to junior team members.
  • Handle and dispose of biohazard material in compliance with OSHA and SOPs.
  • Demonstrate excellent organizational and time management skills.
  • Perform other related duties as required.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
  • Bachelor's degree, in Chemistry or biological sciences preferred
  • 7+ years of related experience in a regulated GMP/GLP setting
  • Working knowledge of standard laboratory practices and safety
  • Capable of effective written and verbal communication
  • Must be able to work independently with minimal supervision
  • Knowledge of MS Office Suite

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