Microbiologist II
Amneal
Summary
This employee supports the Microbiology and Environmental Monitoring (EM) department in implementing and managing the site's microbiology and EM programs as well as the overall microbiology laboratory operations to ensure compliance with current regulations. This position requires direct interaction with the manufacturing processes related to biological non-sterile drug substance and sterile drug product. The employee's qualification in aseptic gown is required.
Job description
Essential Duties & Responsibilities
- Performs environmental monitoring of TPI-controlled and aseptic manufacturing areas.
- Collects samples for the detection of viable (surface, gowning, and air) and non-viable (air) particles.
- Incubates viable samples.
- Streaks and sends representative EM isolates to contract laboratory for identification.
- Receives results and performs data entry for trend analysis.
- Complies with annual gowning qualification.
- Performs sanitation and temperature verification of laboratory refrigerators and incubators.
- Performs routine monitoring for water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems.
- Submits samples for testing to microbiology laboratory or contracted laboratory for TOC, conductivity, microbial count, and endotoxins.
- Performs routine monitoring of compressed air (CA) and nitrogen gas (N2) for viable particles, non-viable particles, oil, and moisture.
- Performs bacterial endotoxin testing of WFI, CS, in process control (IPC), Intermediate product (IP), drug substance (DS), and drug product (DP) samples.
- Performs gram stain and growth promotion tests.
- Performs tests for bioburden and microbial limit.
- Performs visual inspection of microbiological, EM samples and media fill units.
- Performs data entry of results in Excel for trend analysis.
- Reviews microbiology laboratory data.
- Generates OOS or Out of EM Action/Alert Levels Notification, when required.
- Lead laboratory investigations and/or support manufacturing investigations, when required.
- Generate Change Controls for Equipment/Instruments qualifications, Process or Document Changes.
- Lead procedures, methods or specifications revisions acting as Contributor using Master Control System.
- Other tasks as requested by management.
Qualifications
Education: A bachelor's degree in microbiology, biology, or related discipline. Experience: At least 3-5 years of experience in a cGMP pharmaceutical manufacturing environment is required. Working knowledge of cGMP regulations (21 CFR 201/211/820) is required.
Special Skills
- Good written and verbal communication skills.
- Use of air sampling EM equipment, such as AirIdeal, HACH Met Ones 3440 Series, Lasair III, and MiniCapt.
- Good organizational skills.
- Detail oriented.
- Must be able to effectively manage time to complete assignments.
- Familiarized with the use of Microsoft Excel and Microsoft Word.
Work Environment & Physical Demands
General office setting and laboratory settings. Able to work wearing a full aseptic gowning at least 4 hours once weekly. Flexibility working weekend, holidays, or more than 8 hours a day, as required. Exposure to hazardous chemical, such as disinfectants, may occur, requiring personal protective equipment. Safety alertness is required due to work around hazardous equipment and conditions. Must be able to lift up to 25 lbs.
Requirements
- Bachelor's degree in microbiology, biology, or related discipline
- At least 3-5 years of experience in a cGMP pharmaceutical manufacturing environment
- Working knowledge of cGMP regulations (21 CFR 201/211/820)
- Qualification in aseptic gowning
- Good written and verbal communication skills
- Experience with air sampling EM equipment (AirIdeal, HACH Met Ones 3440 Series, Lasair III, MiniCapt)
- Good organizational skills
- Detail oriented
- Ability to effectively manage time to complete assignments
- Familiarity with Microsoft Excel and Microsoft Word
- Ability to lift up to 25 lbs
- Flexibility to work weekends, holidays, or more than 8 hours a day
Benefits
- Health Insurance
- Insurance Benefits
- 401(k) Matching
- Short-term Incentive
- Long-term Incentive
- Restricted Stock Units
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.