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