The QC Lab Scientist III (Micro-Lab) will be involved in testing incoming samples for microbiological testing from different facilities of Amneal Pharmaceuticals. Will perform scheduled monitoring and follow-ups for environmental monitoring at al facilities, and will report to Supervisor regarding any testing-related issues. Performs work maintaining applicable compliance aspects. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Essential Functions:
Validates and tests raw material, in process samples, finished product and stability samples for microbial qualitative and quantitiative testing as per current USP and in house methodology for Total Aerobic Count, Total Yeast and Mold Count, and specified organisms e.g. e. coli, Salmonella spp., S. aureus, P. aeruginosa, etc..
Validates and performs preservative challenge test. Performs all the R&D-related projects as required.
Investigates and documents Microbial Data Deviation (MDD) results.
Samples and tests purified water as raw material for total heterotrophic count and coliforms.
Creates and maintains laboratory records documentation (notebooks and computer based); documents exact steps followed during analysis execution.
Performs all analysis according to written methods, or compendial methods as applicable, using analytical techniques as identified in Standard Operating Procedures (SOPs).
Performs environmental monitoring/cleaning validation of facility (air and surfaces).
Performs identification and interpretation of pharmaceutical significance of isolated from different manufacturing environment.
Prepares and executes protocols, method verifications/validations protocols protocols as and when required.
Additional Responsibilities:
Performs QC checks on prepared media e.g., growth promotion, indicative and inhibitory properties, pH, sterility. Sterilizes glassware and other items.
Decontaminates used/contaminated objects.
Prepares and dispenses culture media.
Performs intra laboratory quality control checks for all equipment.
Responsible for operation of autoclave and performs control procedures, such as bio indicator checks and temperature verification.
Assists other microbiologists as required.
As and when needed, assists Supervisor for handling non-routine special projects requiring activities in the laboratory.
Ensures that expired media, chemicals and reference organisms are removed and replaced in the lab.
Interacts with newly hired laboratory technicians or scientist for providing hands on training on analytical techniques and laboratory instrumentation.
Education:
Bachelors Degree (BA/BS) Microbiology or related field - Required
Master Degree (MS/MA) Microbiology or related field - Preferred
Experience:
5 years or more in With a Bachelor's degree, microbiological testing of pharmaceuticals in a regulated environment.
3 years or more in With a Master's degree, microbiological testing of pharmaceuticals in a regulated environment.
Skills:
Must be precise and consistent in day-to-day analysis, easily trainable, and ready to learn. - Advanced
Must be able to read and understand analytical and microbiological procedures. - Advanced
Must be able to effectively communicate results, problems and issues, verbally as well as in writing. - Intermediate
Must be able to assume a role of a leader in team environment as and when required. - Intermediate
Must be computer literate. Must be willing to work extended hours, including weekends, as and when required. - Intermediate
Must be able to work in a team environment and be flexible to easily adapt to changes in assignment. - Advanced
Should be able to manage the work in fast-moving environment. - Intermediate
Must be able to maintain clear and concise laboratory records and communicate clearly both within and outside the department. - Advanced
Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - 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. - Advanced
Specialized Knowledge:
Basic knowledge of cGMP and aseptic tehniques.
Must possess a working knowledge about microbiology and related tsts as handling of sterile media, organisms, techniques to avoid contamination and perform analyses.
Must be proficient in method validation/verification for <61><62> and preservative challenge test.
Must be able to follow analytical techniques such as weighing, transfer of media in flasks, quantitative addition of additives during media reparation, mathematical calculations involved in preparation of tests and results computations.
Must be able to follow compendial ((USP/EP/JP/BP) procedures for microbiological techniques.
Must have the ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner.