Location: Plainsboro,NJ, USA
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Chemist II 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 and policies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
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.
* Participate in projects involving Quality Control which include new test methods or instrumentation.
* Perform and document instrumental (e.g., UV-VIS, HPLC) and wet chemistry techniques/analyses.
* Perform laboratory testing, as well as general laboratory maintenance, 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.
* 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.
* 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.
DESIRED MINIMUM 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
* 3-5 years of related experience
* 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
TOOLS AND EQUIPMENT USED
Analytical Instrumentation (GC, HPLC, UV-Vis, FT-IR), wet chemistry techniques, computers, along with new and existing manufacturing and test equipment.
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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