Group Leader, Quality Control

Job Summary

The Group Leader role performs testing or reviews records of testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculates and reports results on applicable specification documents, participates in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. The Group Leader also provides project leadership to a small group of scientists and  guidance in the event of analytical problems.

Essential Functions

• Performs/Trains and Reviews chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs).
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyze. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and report results in a timely manner.
• Reviews/Interprets and evaluates data generated by co-workers for accuracy, precision, trends, potential GMP impact and completeness.
• Displays good laboratory techniques to avoid cross-contamination or mis-identification of samples. Ensure Scientist work assignments are prioritized to support project needs.
• Performs/Trains/Reviews physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer, RAMAN, ICPMS.
• Actively participates in and leads  investigation of out-of-specification laboratory results, when required.
• Actively participates in method transfer activities between facilities within the organization or between organizations.
• Leads and tracks execution of method transfer protocols, method verification/validation protocols as and when required.

Additional Responsibilities

• Assists, as and when needed, laboratory supervisor for handling non-routine special projects requiring activities in the laboratory.
• Ensures that expired chemicals and reference standards are removed from the laboratory area, perform calibration of HPLC, GC as assigned by the Supervisor or Manager.
• Interacts with Lab Technicians and Scientists to provide hands-on training on basic analytical techniques and lab instruments.

Education

• Bachelors Degree (BA/BS) in Chemistry or related science discipline - Required
• Master Degree (MS/MA) in Chemistry or related science discipline - Preferred

Work Experience

• 5 years or more Testing of pharmaceutical products ( with Bachelors), and 1 year of leading or supervising projects - Required
• 3 years or more Testing of pharmaceutical products ( With Masters) - Preferred
• 1 year or more Leading projects - Required

Skills and Abilities

• Must be precise and consistent in day to day analysis, easily trainable and ready to learn. Must be able to execute compendial procedures involving complexity. - Advanced
• Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Advanced
• Must be able to assume a role of a leader in team environment as and when required. - Intermediate
• Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Intermediate
• Must be willing to work extended hours, including weekends, as and when required. - Intermediate
• Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Intermediate
• Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Intermediate
• Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate

Specialized Knowledge

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC).
• Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
• Must be able to identify trends in analytical data.