What are the responsibilities and job description for the Quality Control position at 5th HQ?
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
Key Responsibilities:
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
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