Bilingual QC Document Control

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