KEY RESPONSIBILITIES
- Design, develop, maintain, and initiate continuous improvement activities for the material specifications preparation/revisions and execution until it is processed for approval.
- Author and reviewer for test method review, risk assessments, change controls, SOPS, specifications, etc.
- Complete activities in compliance to applicable SOPs, specifications, and compendia requirements in an efficient and high quality manner.
- Evaluate compendia monographs, plan for and order reagents, supplies, instrumentation requirements
- Work closely with others in a team environment within the Quality Control Laboratory and act as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development.
- Coordinates and participates in material review meetings and/or batch readiness meetings.
- Maintain schedule routine maintenance of laboratory instruments for follow up repairs and/or tracking the calibration activities for timely completion
- Working closely with validations team to complete the required tasks for Instrument qualifications process
- Required assistance on record keeping for Laboratory personnel training matrix updates periodically
- Purchasing of laboratory reagents and consumables.
- Perform testing, analysis and data reporting for test samples as needed.
- Inform budgetary decisions for material testing costs.
- Ensure maintenance and calibration of analytical instruments in compliance with SOPS and GMP regulations.
- Develop the Materials testing Training program for QC analysts and lead the training activities.
- Maintain regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other project or material specific documentation with particular attention to accurate record keeping.
- Perform all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.
- Perform additional duties as assigned by laboratory management