We are currently seeking a Quality Control Document Specialist with a strong background in microbiology to support our Quality Control Department. This position plays a key role in ensuring compliance with regulatory standards and maintaining a clean, safe, and efficient laboratory environment.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in Microbiology, Biology, Biomedical Science, or a related field required; Master’s degree preferred
• Minimum of 1 year of experience in a microbiology laboratory within a cGMP-regulated manufacturing environment
• Solid understanding of microbial techniques and methodologies to monitor bacteria, fungi, and other microorganisms
• Familiarity with regulatory requirements and documentation protocols in a laboratory setting

PREFERRED SKILLS:

• Strong attention to detail and documentation accuracy
• Effective communication and collaboration skills
• Ability to work independently and prioritize tasks in a fast-paced environment
• Proficient in Microsoft Office and laboratory data systems

• Follow all procedures and processes to ensure compliance with current Good Manufacturing Practices (cGMP)
• Conduct daily monitoring of microbial cultures in the microbiology laboratory
• Perform laboratory testing and analyses as assigned, including testing of raw materials, finished products, and water samples
• Review analytical assay data for accuracy and compliance; determine acceptability of results
• Inspect manufacturing equipment and personnel for potential sources of contamination
• Support root cause analysis and investigations for out-of-specification (OOS) results
• Maintain clear, organized, and accurate documentation of lab procedures and test results
• Ensure that all work meets established timelines and client or regulatory requirements
• Collaborate with other departments to identify and resolve technical issues
• Contribute to the development and maintenance of safety and compliance standards within the lab
• Provide additional support to the Quality Control Manager as needed