AS Chemist III - Data Integrity Team

The Analytical Services Chemist III role is for a laboratory professional with responsible for performing analytical testing related to raw materials, compounding support activities, and final product testing in the Analytical Services Laboratory. In addition, the Analytical Services Chemist III role will support analytical method validations and transfers, as well as product development studies.

Responsibilities:

• Performing chemical raw material (sampling, testing and release), in-process (including product formulation activities), and final product including stability and complaint sample testing.

• Notify Laboratory Management immediately of out of specification results and assist in the investigations of OOS and deviations as assigned by Laboratory Management.

• Responsible for performing tests associated with method validations and transfers as assigned, including cleaning and equipment validations.

• Responsible for laboratory notebook data, batch record data, and report review when assigned.

• Assist in special projects and regulatory audits as requested by the Laboratory Management.

• Assist in collaboration of laboratory SOPs when requested.

• Responsible for assisting with the training of junior personnel when requested.

• Responsible for ensuring that routine maintenance and troubleshooting of instrumentation, is performed as stated in the instrument manual and contacting the manufacturer for assistance when needed.

• Responsible for the general maintenance of the Chemistry Laboratory including good housekeeping and a safe working environment.

• Follow Standard Operating Procedures, documentation, safety, health, and cGMP Guidelines.

Qualifications

• BS degree in Chemistry or related field with a minimum 4 years of experience, or a MS degree in Chemistry or related field with a minimum 2 years of experience, in a pharmaceutical laboratory environment required.

• Expertise with standard laboratory techniques, wet chemistry tests, titration, spectroscopy, HPLC, GC, and modern Data Acquisition Systems required.

• Competency with specialized laboratory equipment such as ICP-MS, Malvern PSD, aPSD, Particulate Matter testing, Breathing Simulation Testing, etc. is desirable

• Strong documentation skills and proficiency with current word processing, spreadsheets, and database software required

• Must be detail focused, have a strong work ethic, and the ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within the laboratory and between other departments