Senior Quality Specialist
About the Role
The Senior Quality Specialist is responsible for the development and maintenance of the site Quality systems to assure compliance with FDA, ISO, Country specific regulations and standards, and Bausch + Lomb QMS requirements. This individual will support Quality initiatives at both the local and global levels, interact with site functions to assure compliance with regulatory requirements, and provide quality system support for various third-party logistics centers.
Responsibilities
- Nonconformance/CAPA management
- Change Control
- Document Management
- Department Records Management
- Data Integrity
- Validation
- Risk Management
- Training
- Regulated Labeling Maintenance reviews
- Customer Complaints
- Supplier Management
- Auditing (internal/supplier)
- Compilation of site quality/compliance metrics to support Management Oversight inputs
- Verification of released finished goods
- Support the development, implementation, and maintenance of efficient, effective, and compliant quality systems at the distribution level
- Support the systematic control of non-conforming material and corrections/removals
- Coordinate activities of various functional areas during critical quality issues
- Keep senior management updated on compliance issues and propose solutions
- Lead cross-functional teams to drive compliance and quality improvements
- Support external audits
- Provide direction and coordination of quality activities using continuous improvement principles
- Identify systemic weaknesses and lead corrective action initiatives
- Lead failure investigations using root cause analysis tools
Qualifications
- Bachelor's degree in Science or related field
- Minimum 5 years of experience in Quality in an FDA-regulated industry
- Distribution Center experience a plus
- ASQ certification (CQA, CQE, and/or SSBB) desirable
- Experience with logistics systems for inventory control and distribution a plus
- Strong analytical and computer skills (Windows, Word, Excel, PowerPoint, etc.)
Pay
For U.S. locations, the starting pay for this role is between $86,000.00 and $130,000.00. The actual base salary offered may depend on a variety of factors.
Benefits
- Medical, dental, and vision insurance
- Disability and life insurance
- 401(k) plan with company match
- Tuition reimbursement program (select degrees)
- Company holidays and well-being benefits
- Sick time, floating holidays, and paid vacation
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.