Senior Quality Specialist provides quality oversight, GMP guidance and support and makes quality related decisions for the 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, and meet customer needs.
- Review and approve Master Packaging Records for new projects and existing records for updates and all corresponding documentation.
- Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.
- Identifies issues and can independently assess the need for non-conformance and utilizes good judgement and rationale to determine the appropriate containment actions in conjunction with operational leadership.
- Proactively identify and facilitate resolution of potential risks.
- 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 (operations, sales, customer service, project management, validation, and engineering) to ensure compliance of processes and product.
- Author, review and / or approve quality documentation including work instructions, SOPs, Quality Forms, etc.
- Provide Regulatory and Customer Audit Support /assist in providing observation response.
- 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.
- Ability to simultaneously manage multiple tasks.
- Must be flexible to meet the needs to the organization when required.
Benefits
- Pre-employment drug test
- Background check
