Associate Scientist, Quality Control

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.

Qualifications:

Qualifications

Education:

• Bachelors Degree (BA/BS) Microbiology or related field – Required

Experience:

• 1 year or more in Testing of chemicals/pharmaceutical products

Specialized knowledge:

• Must possess a working knowledge of analytical microbiology techniques, such as handling of sterile media, organisms, techniques to avoid contamination and perform analyses. Must be able to follow the analytical techniques as weighing, transfer of media in flasks, quantitative addition of additives during media preparation, mathematical calculations involved in preparation of tests and results computations. Must be able to perform enumeration testing Must understand and apply cGMP requirements applicable to Quality Control laboratory in a pharmaceutical environment.
• Must be able to follow directions to use chemicals as identified on applicable MSDS for safe usage. 
• Must be computer literate and be able to use MS Office software applications. 
• Must be able to follow compendial (USP/ EP/ JP/ BP) procedures for microbiological techniques.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Must follow applicable state and federal regulations

The base salary for this position ranges from $65,000 to $85,000 per year.   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.

Salary : $65,000 - $85,000