Bilingual QA Document Control Specialist

We are currently seeking a Bilingual  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