Description:

The Scientist 3 - QCTS is responsible for performing all analytical method development, qualifications and method validations for active pharmaceutical ingredients, excipients, and the finished product pharmaceutical dosage forms. This individual performs testing of in-process and release activities to support post approval changes related to manufacturing and raw material/packaging component related changes. This role will support all testing related to alternate source qualification of API, excipients, and packaging components. This role will also support testing required for continuous compliance to applicable monographs and compliance to all existing and new guidance. This individual will participate in method transfer activities within departments or between facilities or organizations. This individual analyzes organic or inorganic compounds using chromatography, spectroscopy or spectrophotometry techniques and conduct quality control tests. This individual maintains laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed. The Scientist-3 assists Group Leader/Manager with training other scientists for analytical instrument/equipment.

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 situation. Assure compliance with state and federal regulations.  Perform testing using HPLC, UPLC, GC, ICPMS, ICP-OES, GCMS, LCMS, IR, UV, Malvern Mastersizers, XRD, Dissolution, Karl-Fischer titrator, analytical balances, and other instruments as required. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.

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 laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.