Responsibilities
- Carry out standard reagent production for diagnostic assays, including support during development, verification, and validation phases.
- Conduct quality control assessments and analyze data to confirm reagent quality and adherence to specifications.
- Keep precise and compliant records following cGMP requirements, such as batch documentation, equipment logs, and system reports.
- Track and manage raw material and finished product inventory to ensure continuous manufacturing operations.
- Maintain clean, orderly production spaces that meet safety and contamination control standards and are prepared for audits.
- Confirm that lab instruments are calibrated and up to date with preventive maintenance schedules.
- Assist in diagnosing and resolving issues related to equipment, processes, or product quality through root cause evaluation.
- Take part in investigations of non-conformances, including determining dispositions and carrying out corrective and preventive actions.
- Support change control initiatives, such as updating documentation, modifying processes, and resolving deviations.
- Lead or assist in validation projects, from creating protocols to executing tests and preparing final reports.
- Offer feedback on revisions to manufacturing documents and suggest improvements for clarity and efficiency.
- Help train new team members to follow production procedures and operational guidelines effectively.
- Independently organize tasks and manage workload to meet deadlines in a fast-paced setting.
- Complete other assigned duties that support team performance and operational goals.
Work Arrangement
On-site — Brisbane, CA
Other
- This position requires physical presence at the Brisbane, CA site.
- Travel is not a regular requirement, though occasional travel may be necessary.
- Work may involve exposure to environments with ongoing safety, health, and environmental considerations.
- Compliance with corporate and regulatory policies in safety, health, and environment is mandatory.
- The role involves frequent sitting, standing, and walking during work hours.
- Employees may sit continuously for 3 to 4 hours at a time during the workday.
- Regular use of hands is needed for operating office and lab equipment, including keyboard input.
- Occasional lifting or moving of items weighing up to 20 pounds is required.
- Required visual capabilities include close-range vision and the ability to adjust focus.
