Senior Quality Specialist

Bausch + Lomb • US-VA-Lynchburg, VA

2d

About The Position

The Senior Quality Specialist develops and maintains site Quality systems to ensure compliance with FDA, ISO, country-specific regulations and standards, and Bausch + Lomb QMS requirements. The role supports Quality initiatives at local and global levels and works with site functions to maintain regulatory compliance. It also supports quality-system activities at third-party logistics centers and distribution operations, including product record reviews and system release.

Requirements

• Bachelor's degree in Science or a related field.
• At least 5 years of Quality experience in an FDA-regulated industry.
• Strong analytical and computer skills, including Windows, Word, Excel, and PowerPoint.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice To Haves

• Distribution Center experience.
• ASQ certification such as CQA, CQE, and/or SSBB.
• Experience with logistics systems for inventory control and distribution.

Responsibilities

• Manage and support nonconformance/CAPA, change control, document and records management, data integrity, validation, risk management, training, regulated labeling maintenance reviews, customer complaints, supplier management, and internal and supplier audits.
• Compile site quality and compliance metrics to support management oversight.
• Verify released finished goods.
• Provide quality-system support to third-party logistics centers as requested.
• Support the development, implementation, and maintenance of effective, compliant distribution-level quality systems, including product record reviews and system release.
• Support systematic control of non-conforming material and corrections or removals where applicable.
• Coordinate functional-area activities when critical quality issues are discovered.
• Keep senior management informed of compliance issues and propose solutions and action plans.
• Lead cross-functional teams to drive compliance and quality improvements across departments and sites.
• Support external audits as assigned.
• Direct and coordinate quality activities using continuous quality improvement principles and methodologies.
• Identify systemic weaknesses and lead corrective-action initiatives where applicable.
• Independently lead failure investigations using root-cause analysis tools, and propose and implement systematic corrective and preventive actions.

Benefits

• Medical, dental, and vision insurance.
• Disability and life insurance.
• 401(k) plan and company match.
• Tuition reimbursement for select degrees.
• Company holidays, sick time, floating holidays, and paid vacation.
• Well-being benefits.
• U.S.-based employees may be eligible for short-term and/or long-term incentives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior