Microbiologist I - Quality Control Specialist

Work Schedule and Environment

Initially operate during standard office hours with future transition to a 12-hour rotating shift schedule. Work must be conducted adhering to strict Good Manufacturing Practices (GMP) and safety protocols within a cleanroom environment where personal grooming and attire restrictions apply (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair). Personal protective equipment (PPE) such as safety glasses, gowns, gloves, lab coats, and ear plugs are mandatory.

About Thermo Fisher Scientific

Join a global team committed to advancing science for a healthier, cleaner, and safer world by developing innovative solutions tackling critical challenges including environmental protection, food safety, and cancer research. We empower our employees with resources to support their career development and contribute meaningful work every day.

Job Description

As a member of the Quality Control team, you will focus on ensuring product quality and reliability by conducting microbiological testing and analysis throughout the product lifecycle, supporting innovative therapeutic development. Your role includes quality control testing of raw materials, in-process samples, and finished goods using diverse analytical techniques, documenting and interpreting results, participating in investigations, and engaging in ongoing improvement initiatives. This position offers growth opportunities while collaborating with experienced colleagues dedicated to excellence and innovation.

Primary Responsibilities

• Conduct quality control microbiological tests on raw materials, incoming goods, intermediates, and finished products under current Good Manufacturing Practices (cGMP) for product release and stability studies.
• Take part in method transfer, verification, and validation activities for newly introduced products.
• Monitor utilities systems within the facility.
• Support qualification processes for laboratory equipment.
• Coordinate equipment maintenance and calibration tasks.
• Assist with aseptic process simulation exercises.
• Prepare and periodically review laboratory documentation.
• Manage and maintain microbiological test inventory.
• Ensure laboratory data integrity through accuracy and completeness.
• Maintain comprehensive individual training records.
• Engage actively in continuous improvement practices.
• Strictly comply with cGMP in daily work operations.
• Implement 5S principles focused on Health, Safety, Environmental, and cGMP standards.
• Perform additional duties as assigned by supervisory personnel.
• Be prepared to support shift work as required.
• Adhere to emergency protocols and safe work procedures consistently.
• Uphold environment, health, safety, and security policies, signage, and instructions at all times.
• Promptly report and assist in investigating accidents, near misses, or breaches of safety rules.

Candidate Requirements

• Bachelor’s degree with 1-2 years of experience in a quality control laboratory, preferably within pharmaceutical or biotechnology sectors.
• Preferred academic backgrounds include Microbiology, Biotechnology, Biology, or related scientific disciplines.
• Comprehensive knowledge of cGMP, Good Laboratory Practice (GLP), and quality management systems.
• Proficiency in microbiological testing methods and aseptic techniques.
• Competent in following Standard Operating Procedures (SOPs) and maintaining detailed documentation in compliance with Good Documentation Practices (GDP).
• Strong computer literacy including Laboratory Information Management Systems (LIMS), Microsoft Office, and analytical software.
• Exceptional attention to detail and organizational abilities.
• Robust analytical and problem-solving skills.
• Able to work independently as well as collaboratively.
• Clear verbal and written communication capabilities.
• Experience with calibrating and maintaining laboratory instrumentation.
• Familiarity with pharmacopeia standards and applicable regulatory requirements.
• Capable of prioritizing multiple tasks efficiently.
• Flexibility in work scheduling may be necessary.
• Physical aptitude for laboratory duties, including PPE usage.