Job Summary

The Scientist 1 - QCTS is an entry level, and it contributes to tasks associated with qualifications and method validations for active pharmaceutical ingredients, excipients, and the finished product pharmaceutical dosage forms. The individual is also responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.

Essential Functions

• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, according to written methods, protocols, material specification, and company policies as identified in standard operating procedures (SOPs) to support method validation/verifications. Comply with CGMPs, SOPs, and STPs to avoid out-of-specification situations. Assure compliance with state and federal regulations.

• Utilize techniques of Spectrophotometry, HPLC, GC, dissolution, and wet chemistry tests in accordance with the USP.

• Actively participate in any project work as and when assigned. Creates and maintains laboratory record documentation and interpret and communicate analytical results.

• Report any abnormal findings to the Supervisor. Actively participates in investigation of laboratory results, when required. Contribute to technical problem solving and troubleshooting as needed.

Additional Responsibilities

• Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from the laboratory area. Performs ordering of new projects reference standards, chemicals and HPLC, GC columns.