Microbiologist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position: QC Microbiologist II

Location: Greenville,NC 27834

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite


Shift Timings: Monday To Friday From 08:00 AM to 05:00 PM


Summary

QC Scientist II / QC Microbiologist II responsible for performing moderately complex microbiological testing in a pharmaceutical laboratory environment. Supports manufacturing and internal development activities by testing raw materials, in-process samples, finished products, stability samples, and production intermediates. Ensures accurate documentation and reporting of laboratory results while maintaining compliance with SOPs, GMP, GLP, safety, and applicable regulatory requirements. Supports method development, validation, troubleshooting, and continuous improvement activities.

Responsibilities

• Perform microbiological testing of in-process and finished products using validated, internally developed, and compendial methods.
• Conduct testing for Bioburden, Bacterial Endotoxin, Particulate Matter, Sterility, and Water.
• Test raw materials, stability samples, production intermediates, and other laboratory samples.
• Identify, investigate, and report out-of-specification (OOS) and unexpected results.
• Troubleshoot analytical instruments and laboratory equipment as needed.
• Document, review, and communicate laboratory test results accurately.
• Record and report analytical results according to laboratory procedures and systems.
• Interact with clients and internal departments as required.
• Prepare and assist with regulatory documentation for internal projects.
• Communicate with corporate sites, agencies, external departments, and clients.
• Write and revise SOPs and instructional documents.
• Support microbiological method development and validation activities.
• Recommend solutions for non-routine analytical and product-related problems.
• Maintain and organize laboratory work areas, instruments, and testing materials.
• Maintain adequate inventory of laboratory commodities required for testing.
• Follow SOPs, GMP, GLP, safety guidelines, and company compliance requirements.
• Support process improvements and laboratory efficiency initiatives.

Required Skills

• Bachelor's degree in Biology, Chemistry, or a related scientific discipline preferred.
• Associate degree in Biotechnology or a related science field minimally required; relevant industry experience may be considered.
• 3+ years of experience in a pharmaceutical microbiology laboratory or related environment.
• Knowledge of qualitative and quantitative microbiological testing.
• Understanding of microbiological method development and validation.
• Knowledge of chemistry and analytical instrumentation technologies.
• Experience with LIMS, SLIM, TrackWise, or Documentum is a plus.
• Reviewer, approver, or qualified checker experience preferred.
• Knowledge of pharmaceutical quality and regulatory requirements.
• Ability to write SOPs and method validation reports.
• Ability to read and interpret technical procedures and government regulations.
• Strong mathematical, analytical, and problem-solving skills.
• Strong interpersonal and communication skills.
• Highly organized, detail-oriented, and self-motivated.
• Strong time-management and organizational skills.
• Ability to work independently and collaboratively in a team environment.
• Ability to adapt to changing priorities and laboratory requirements.
• Customer-focused mindset with a strong sense of accountability.
• Ability to identify and implement process improvements.
• Ability to safely perform laboratory work involving prolonged standing, walking, bending, lifting, and required PPE.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.