Microbiologist

Microbiologist

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, endotoxin testing, Microbial Limits Testing, Antibiotic Assay, 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.

Responsibilities:

• Preparing and performing microbiological tests on cosmetics and pharmaceuticals as recommended by current USP, FDA, and AAMI/ISO regulations.
• Routine Quality Control of laboratory equipment, media, and microorganisms.
• Provide accurate test results to customers on a timely basis including but not limited to Microbial Limits Testing, Limulus amoebocyte lysate (LAL), Sterility, etc.
• Record test results accurately and legibly on all documents.
• Technical report writing including text, tables, graphs, and diagrams.
• Assist in the training of new Laboratory Technicians.
• Follow and perform process qualifications and validations for procedures and/or equipment.
• Maintain control of test samples including logging in, storage, tracking, and disposal.
• Monitor test status and conditions as described in Work Instructions and Operating Procedures.
• Routine maintenance of laboratory environment to include cleaning and troubleshooting.
• Report any deviations and/or nonconformities to Management.
• Suggest possible preventative and corrective measures to prevent future deviations and nonconformities.
• Inventory of laboratory supplies to maintain par levels.
• Gowning and garbing for cleanroom settings.
• In cooperation with the Laboratory Manager, responsible for the qualification, maintenance, and calibration of critical equipment.
• Update procedures for improvement to methods.
• Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.
• Other duties as assigned.

Qualifications

Must have:

• 3-7 years of experience performing microbiological laboratory tests for Pharmaceuticals and cosmetics.
• Bachelor's degree in Microbiology.
• Ability to Successfully Pass Background and Drug Screen

Education:

• Bachelor's degree in Microbiology or related life science

Experience:

• 3-7 years of experience performing basic microbiological laboratory tests including but not limited to Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc.
• 3 year of experience with GMP/ISO/USP, etc.

Competencies:

• A highly competent and proficient worker, capable of multi-tasking, being self-motivated, and taking initiative.
• Personal attributes should include honesty, integrity, adaptability, reliability, and positivity.
• 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, 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.

Additional Information

Positions are full-time, working Monday-Friday 8am-5pm with rotating Saturday schedule, overtime as needed. Candidates currently living within commutable distance to North Brunswick Township, NJ are encouraged to apply.

Pay range: $60,000 - $65,000 depending on related experience.

Excellent full time benefits including comprehensive medical coverage, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays.

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.