Overview

Responsibilities

• The Analytical QC Analyst II is an integral part of the team, contributing to our success by performing raw materials and commercial pharmaceutical products testing according to compendial methods and/or internal standards test procedures (STPs).
• Conducts Analytical testing of Raw Materials, Intermediate Products and Finished products as per written procedures and protocols to support material/product release, stability studies, method transfers, method verifications and investigations.
• Troubleshoot, operate, and train for testing associated with general analytical instruments for testing of raw material, in process and finished products using instruments such as HPLC, GC, Dissolution, UV, IR, automatic titrator, and viscometer.
• Ensures testing is properly conducted and documented for all performed activities with emphasis on data integrity.
• Prepare test solutions, volumetric solutions, and samples used in analysis.
• Performs assigned physical tests, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, components, and stability products in an FDA regulated lab environment.
• Notifies supervisor immediately regarding testing abnormalities, OOS/OOT results, and deviations from established testing procedures. Serves as a lead investigator in conducting and documenting the investigation.
• Functions as a subject matter expert within the analytical laboratory and always provides support.
• Performs training and provides technical support to junior analysts as required.
• Works under minimal supervision and is expected to independently carry-out non-routine assignments.
• Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic.
• Maintains proper documentation of laboratory data (which requires adequate proficiency in written and computational skills).
• Reviews analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and our procedures/protocols.
• Reviews and/or writes technical reports, procedures, and protocols.
• Draws conclusions from data and communicates those conclusions is writing.
• May Schedule laboratory testing and associated activities to minimize operational disruptions to departments.
• May manage inter-departmental projects to ensure timely completion of objectives.
• Completes any other duties assigned by QC management as required.

Qualifications

• Minimum of four years of experience with a bachelor s degree in chemistry or related scientific field required. Alternately, three to six years of experience with a master s degree in chemistry or related scientific field. Alternately, zero to three years of experience with a PhD in chemistry or related scientific field.
• Minimum four years of pharmaceutical or related industry experience.

• Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e. HPLC, GC, Dissolution) and a good understanding of separation theories.
• Candidate must have broad knowledge in all types of compendia testing (USP, EP, JP, BP) and wet chemistry techniques.
• Good written English and verbal communication skills.
• Must be highly organized and able to work under pressure.
• Must have strong interpersonal and leadership skills.
• Must be computer literate with knowledge in all Microsoft business applications.
• Strong background in scientific software such as Waters Corp. Empower and LIMS is a plus.

• Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within framework of departmental or functional guidelines, requiring interpretation and original thinking.

• A laboratory environment with exposure to chemicals, caustics, fumes, heat and electrical current.