AS Chemist II - Data Integrity Team

The Analytical Services Chemist II role is for a developing laboratory professional with responsible for performing analytical testing related to raw materials, compounding support activities, and in-process and finished product testing in the Analytical Services Laboratory. Other responsibilities include sampling, testing, and releasing of utilities.

Responsibilities:

• Performing chemical raw material (sampling, testing and release), in-process (including product formulation support activities), and finished product (including stability and complaint) sample testing.
• Responsible for performing tests associated with method validations and transfers as assigned, including cleaning and equipment validations.
• Responsible for data and/or document review when assigned.
• Notify Laboratory Management immediately of out of specification results and assist in the investigations of OOS and deviations as assigned by Laboratory Management.
• Assist in special projects and regulatory audits as assigned by Laboratory Management.
• Assist in collaboration of laboratory SOPs when assigned.
• Responsible for ensuring new logbooks are acquired and coordinating documents ready for off-site storage.
• Responsible for assisting with employee training when assigned.
• Responsible for ensuring inventory is performed and assisting with ordering when assigned.
• Responsible for ensuring that routine maintenance 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 Analytical Services 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 of 2 years of experience in a pharmaceutical laboratory environment, or a MS degree in chemistry or related field
• Competency with standard laboratory techniques, wet chemistry tests, titration, spectroscopy, HPLC, GC, and modern Data Acquisition Systems required
• 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