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.
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.
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.