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The Chemist I 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 is responsible for operating in compliance with all applicable procedures and policies.

SUPERVISION RECEIVED

Under direct supervision of Supervisor, QC Analytical

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.

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.

Submit samples for shipment to third-party labs when necessary.

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.

Assist with proper execution of laboratory Out-of-Specification (OOS) investigations.

Complete data entry for trending reports for In-process and Finished Goods Quality Control Testing, as well as Stability Testing.

Train team members in Analytical department as assigned.

Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.

Demonstrate 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

0-3 years of relevant GMP/GLP laboratory experience in regulated industry preferred

Capable of effective written and verbal communication

Must be able to work independently with minimal supervision

Knowledge of MS Office Suite

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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