Associate Scientist, Microbiology - 2nd Shift

Amneal Pharmaceuticals LLC; United States; On-site; USD 68,000 - 80,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an Associate Scientist, Microbiology in the United States. The role performs testing of air, water, raw materials, in-process and finished dosage forms, including stability scenarios, and reports results per established SOPs.

Responsibilities include preparing culture media, performing quality checks, maintaining lab records, and supporting investigations while adhering to cGMP guidelines and safety practices. Entry-level with growth potential.

Qualifications

• Bachelor’s degree in Microbiology or related field required.
• 1 year or more in testing of clinical/pharmaceutical products.
• Working knowledge of analytical microbiology techniques and cGMP in QC.
• Proficient in documenting methods, results and calculations.

Responsibilities

• Perform microbiological analysis of air, water, raw materials and finished products per SOPs.
• Prepare culture media and perform quality checks, including pH and sterility.
• Maintain laboratory notebooks and computer records, documenting steps clearly.
• Investigate laboratory results and assist with instrument checks and calibration.

Skills

Aseptic techniques

Plating techniques

Dilution & enumeration

Sterile media handling

Quality control

cGMP compliance

Laboratory documentation

MS Office

Autoclave operation

Regulatory awareness

Education

Bachelor's degree in Microbiology

Tools

Vitek

API strips

Culture media preparation

Autoclave operation

Job description

Description:

The Associate Scientist, Microbiology 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.

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.

Education:

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

Experience:

• 1 year or more in Testing of clinical/ 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 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.

Salary

The annual rate for this position ranges from $68,000 to $80,000 annually. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what 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, experience, geographic location and other relevant skills.

Benefits

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 help you enjoy your career alongside life’s many other commitments and opportunities.