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 as well as interact with site functions to assure compliance with regulatory requirements.
Key Responsibilities- Nonconformance/CAPA, 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, and verification of released finished goods.
- Quality system support for various third-party logistics centers as requested.
- Support the development, implementation, and maintenance of efficient, effective, and compliant quality system at the distribution level supporting product record reviews/system release.
- Support the systematic control of non-conforming material and corrections/removals where applicable.
- Coordinates activities of the various functional areas whenever a critical quality issue is discovered.
- Keeps senior management updated on all compliance issues that occur and proposes solutions with action plans to resolve.
- Leads cross functional teams to drive compliance and quality improvements across departments and sites.
- Supports external audits as assigned.
- Provides direction and coordination of quality activities utilizing continuous quality improvement principles and methodologies.
- Identifies area of systemic weakness and leads initiatives to implement corrective action where applicable. Independently leads failure investigations, using root cause analysis tools, and proposing, implementing systematic corrective and preventive actions.
Qualifications- Bachelor's degree in Science or related field.
- Minimum 5 years 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 to include Windows, Word, Excel, Power Point, etc.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $86,000.00 and $130,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement
Our US Benefit Programs Employee Benefits: Bausch + Lomb
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.
