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.
Essential Functions:
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.
Additional Responsibilities:
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.
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.
Education:
Bachelors Degree (BA/BS) Microbiology or related science discipline - Required
Master Degree (MBA) Microbiology or related science discipline - Preferred
Experience:
3 years or more in Bachelors Degree (BA/BS) -Testing of pharmaceutical products, 3 years or more
1 year or more in Master Degree (MA/MS) -Testing of pharmaceutical products, 1 year or more
Skills:
Must be precise and consistent in day-to-day analysis, using sophisticated analytical instruments. - Advanced
Must be familiar with out of specification 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 or 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 assignments. - 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
Must be able to assume a role of a leader in team environment as and when required. - Beginner
The annual base salary for this position ranges from $75,000 to $95,000. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
