Lab Technician

JOB DESCRIPTION

Job Summary:
Reporting to the Microbiology Lab Supervisor, the Sr. QC Technician is responsible for supporting activities within the Microbiology Lab. The role performs studies and microbiology testing required by established work instructions, procedures, protocols, and standards. The technician must exercise accuracy and attention to detail, maintain accurate records, and ensure compliance with internal Quality Assurance procedures and external standards and regulations.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
- Responsible for sterility testing (SDAs and BI, if applicable), non-sterile bioburden testing and particulate testing while maintaining a sterile field.
- Responsible for LAL testing and associated validations/revalidations.
- Responsible for supporting training and testing and ensuring turnaround times are met.
- Environmental monitoring of the laboratory, controlled areas, and lab spaces as applicable.
- Preparing media for testing, quality checks, and sterilization of testing equipment.
- Metrics, gathering and trending of test data.
- Review QMS documents and procedures prior to release or update as required.
- Proactively identify compliance issues and verify alignment with internal and external standards
and policies.
- Notify and work closely with functional management when OOS occurs.
- Maintain a positive and cooperative team dynamic.
- May assist in the design and implementation of new laboratory equipment.
- Other duties as assigned.
- Support training initiatives and training of new associates

Education and Experience:
1. Typically requires a minimum of a Bachelor's degree in science (Microbiology or Biology
related) with 5+ years relevant experience in a related discipline.
2. Understanding of ISO 13485, 21 CFR 820 and other related standards.