Microbiology Lab Analyst II (Sterility testing)

Must have:

Bachelor’s degree in Microbiology
1 - 3 years of microbiology laboratory experience with USP <71> Sterility
Able to successfully Pass Background and Drug Screen
Summary:

Job Summary:

Candidates in this role are responsible for the accurate and efficient execution of microbiological tests including aseptic processing of sterility tests in a cleanroom suite, particulate matter testing via the use of a laser particle analyzer or microscopic examination, endotoxin testing, or other microbiology pharmaceutical testing in accordance with established procedures. Candidates Will collect and present data in a well-reasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.

Essential Duties/ Responsibilities:

Perform routine preparation of samples and reagents used for testing analysis
Schedule samples based on priority.
Perform standard testing of samples using various methods and instruments that can
include but not limited to Particulate Matter Testing, Sterility Testing, Endotoxin
Testing, Container Closure Testing, Proficiency Testing, and Sample Validations
Analyze the results of testing to identify concerns or issues and discuss them with a supervisor as needed.
Report and document results following established procedures.
Assist in writing Standard Operating Procedures and Work Instruction
Perform peer technical review for test results.
Education:

Bachelor’s degree in microbiology or a related field or related field from an accredited college or university.
Experience:

1 – 3 years of microbiology laboratory experience with USP <71> Sterility.
Experience with <61>Microbial Enumeration,<62> Microbial Identification <51> AET, <85> Bacterial Endotoxin, <788> <789> Particle Size, preferred.
1 year of experience with GMP/ISO/USP, etc.
Competencies:

Highly competent and proficient worker, capable of multi-tasking, being self-motivated,
and takes initiative.
Personal attributes should include honesty, integrity, adaptability, reliability, and
Positive.
Displays leadership skills, is able to train/teach others, and possesses high quality.
Standards.
Able to provide root cause analysis and corrective action for Out of Specification Results.
Exhibits troubleshooting skills involving equipment-related issues.
Maintains personal hygiene and cleanliness inside and outside the microbiology laboratory.
Adherence to ISO/GMP/USP standards and completion of necessary training modules
Abilities in mathematical reasoning, arm-hand steadiness, finger dexterity, visual color differences, and deductive reasoning.
Knowledge of laboratory equipment such as microscopes, velometers, balance, autoclaves, water purification systems, hood operation, particulate counter, membrane filtration, endotoxin plate reader, etc.
Standard office equipment including computers, copiers, and scanners.
Frequently requires the use of potentially hazardous chemicals and reagents. Must be
able to lift up to 30 pounds.
Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.