Job Title: Sr Quality Control Associate Technical Services
This position is responsible for the planning, execution, and documentation of laboratory system qualification, calibration, and routine maintenance in a cGMP regulated environment. The ideal candidate will have hands-on experience with laboratory equipment lifecycle and validation.
Responsibilities
* Plan and conduct routine calibration, requalification, and maintenance of laboratory equipment to ensure adherence to schedules.
* Review and file quality control calibration and maintenance documentation.
* Document the qualification of new laboratory equipment in a cGMP regulated environment, including writing equipment validation protocols and summary reports.
* Conduct periodic reviews of instrument validation as part of the validation life cycle.
* Alert quality management in the event of equipment failing to meet calibration or qualification requirements.
* Schedule and coordinate equipment repairs and maintenance with vendors/contractors.
* Participate in technical project teams as a subject matter expert on instrument validation regulations and procedures.
* Owning and managing change controls and adherence to Change Control metrics.
* Supporting and managing the addition of project components to CMMS Maximo.
* Acting as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
Qualifications
* Bachelor's degree in a Science-related field.
* Minimum of 3 years of laboratory experience in a cGMP laboratory environment.
* Detailed knowledge of analytical techniques used for biopharmaceutical testing.
* Understanding of current regulatory requirements for cGMP laboratory equipment validation.
The ideal candidate will have demonstrated success in managing an equipment qualification or maintenance program. If you have the required skills and qualifications, please apply now.