The Scientist II - QC is responsible for performing testing of purified water, viable air samples, raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method verification activities. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Performs microbiological analysis of water, 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 aseptic techniques, plating techniques, dilution and enumersastion techniques adhering to company policies as identified in standard operating procedures (SOPs). Prepares samples for analysis involving aseptic techniques and proper sample handling techniques as applicable. Perform Identification of organisms.
Prepares culture media and perform s its Quality checks such as pH, sterility, Growth promotion, Indicative and inhibitory properties check. Performs media weight loss test, culture controls, preparation and maintenance of organism slants identification of organisms using staining and biochemical techniques such as Vitek and API strips.
Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
Participate in scheduled Environmental monitoring and follow-up of monitoring at all facilities.
Actively participates in and leads investigation of out of specification laboratory results when required.
Perform and execute protocols as required.
Assists, as and when needed, senior scientists working in the laboratory. Ensures that expired media and reference organisms are removed from laboratory area. Sterilization of glassware and other items. Decontamination of used/contaminated objects. Preparation and dispensing of culture media. Perform intra laboratory Quality control checks for all equipment. Responsible for operation of autoclave and perform control procedures as bio indicator checks and temperature verification. Assisting other Microbiologists as required.
Bachelors Degree (BA/BS) Microbiology or related science discipline - Required
3 years or more in 3 years or more experience testing of pharmaceutical products.
Must be precise and consistent in day-to-day analysis, using sophisticated analytical instruments. - Advanced
Must be familiar with out of specifications and out of alert limit investigations. - Intermediate
Must be able to execute compendial procedures involving complexity - Intermediate
Must be familiar with cGMP and OSHA regulations - Intermediate
Must be able to effectively communicate results, problems and issues, verbally as well as in writing. - 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 assignment. - 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 able to maintain clear and concise laboratory records and communicate clearly both within and between the department. - 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
Must be able to assume a role of a leader in team environment as and when required. - Beginner