Quality Control Specialist

Piramal Enterprises - Lexington, KY

Lexington, KY

Securities, Commodity Contracts, and Other Financial Investments and Related Activities

About the position

The position involves a range of responsibilities centered around the design, development, and maintenance of material specifications within a Quality Control Laboratory. The role requires continuous improvement activities for material specifications preparation and revisions, ensuring compliance with applicable SOPs and specifications. The individual will work closely with multidisciplinary teams to support Manufacturing and Product Development, while also coordinating material review and batch readiness meetings. Additionally, the position includes responsibilities for maintaining laboratory instruments, record keeping, and training QC analysts.

Responsibilities

• Design, develop, maintain, and initiate continuous improvement activities for material specifications preparation and revisions.
• Author and reviewer for test method review, risk assessments, change controls, SOPs, specifications, etc.
• Complete activities in compliance with 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.
• Coordinate and participate 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.
• Work closely with the validations team to complete the required tasks for Instrument qualifications process.
• Assist with record keeping for Laboratory personnel training matrix updates periodically.
• Purchase 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 safe operation of laboratory equipment.
• Perform additional duties as assigned by laboratory management.