What are the responsibilities and job description for the Associate Scientist, Quality Control position at Amneal?
The Scientist 1 - QC is an entry level role responsible to perform testing of air, water, raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.
Schedule:
1st Shift - 7am - 3:30pm Monday to Friday
Essential Functions:
- Performs microbiological analysis of air, 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 enumeration 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
- Prepares culture media and perform 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
- Actively participates in investigation of laboratory results, when required
Additional Responsibilities:
- Informs QC Group leader if media or standard organism is expired for removal from laboratory area.
- Performs Purified water and viable air sampling as required.
- Perform daily instrument/ equipment checks such as Balance weight verification, incubator temperature checks and maintenance of all equipment in the lab.
- 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.
