Senior Quality Specialist

Senior Quality Specialist provides quality oversight, GMP guidance and support, and makes quality-related decisions for designated functional areas within Sharp Commercial sites.

Requirements

• Collect and summarize data, draw conclusions, turn recommendations into clear communication.
• Lead and take active role in non-conformance investigations.
• Manage relationships with customers, ensuring quality standards are aligned.
• Review and approve Master Packaging Records for new projects and existing records for updates.
• Complete QMS actions related to change controls, non-conformance, complaints, and CAPAs.
• Implement methods for process control, process improvement, testing, and inspection.
• Ensure testing and inspection meet internal and external requirements.
• Audit internal processes on shop floor and warehouse and support internal stakeholders.
• Author, review, and / or approve quality documentation including work instructions, SOPs, Quality Forms, etc.
• Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls.
• Collect and present customer KPIs as required.
• Oversee testing equipment calibration to ensure timely calibration and repair.
• Support DEA requirements and DEA Compliance
• Support training department to identify new opportunities for training program.
• Train colleagues
• Ability to serve as the alternate for the Quality Manager role during Manager’s absences as requested.
• Provide support to the audit team for items relevant to quality processes and procedures.