Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting
The QC Microbiologist-I is responsible for the complete testing and results documentation of any of the following: Raw Materials, In-Process, Finished Product, Stability, Technical Service samples or projects within the QC Microbiology Laboratory, in a manner consistent with established standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Testing/Documentation:
Perform microbiological testing including identification of micro-organisms, water activity, bioburden, and growth promotion testing.
Ensure all microbiological procedures reflect current practice and complies with current USP/EP requirements.
Perform the routine Environmental Monitoring program on site.
Collect plant purified water and perform nitrate, chlorine, pH, TOC, and conductivity, and microbial testing.
Prepare media, and/or use the commercially prepare media for microbial testing, and autoclave for waste disposal.
Perform any microbial alert/action required from routine EM, water, microbial testing, etc.
Drive a culture of continuous improvement by employing Practical Process Improvement concepts, reporting metrics, and communicating internally to diverse audiences.
Perform other duties as assigned.
Standardizations/ Preparatory Set Up
• Perform daily verifications of instruments such as balances, pH meters, and pipettor as required by work instructions.
• among other solutions including microbiological solutions.
• Prepare media, and other microbiological solutions, use the Autoclave for waste disposal.
Order and receive lab supplies and maintain inventory of lab supplies.
Housekeeping:
Clean and organize all laboratory areas including bench, sinks, drawers, cabinets, solvent cabinets, fume hoods, refrigerators, freezers, desiccators, and storage areas.
Occasionally clean laboratory pipettes and other glassware.
Maintain laboratory instruments disposing of wastes, cleaning them, and replacing consumable parts as required. Maintain 5’s cleaning/ visual management in the laboratory.
Training and Development
• Participate in ongoing training for the development of skills and responsibility with an emphasis on technology.
• Assist training of other analysts in areas of expertise.
EDUCATION AND EXPERIENCE:
Bachelor’s Degree from an accredited college/university in Chemistry, Microbiology, Biology, Biochemistry, Biotechnology, or related field. Microbiology degree strongly preferred with 0-5 years of related experience preferably in a Quality Control Laboratory in a GMP facility.
KNOWLEDGE, SKILLS, ABILITIES:
Must demonstrate a high level of commitment to delivering timelines and breakthroughs to achieve business objective.
Ability to apply GMP regulations and international guidelines to all aspects of the position.
Excellent communication and listening skills
Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
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