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Quality Specialist
3 months ago
TSX:
BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life.
Our mission is simple, yet powerful:
helping you see better, to live better.
Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives.
We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.
We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
Objectives:
Direct the Quality organization in the building and assessment of quality into all pertinent systems and processes. Drive and foster quality improvement of products and processes. This individual is the top Quality leader at the Bausch & Lomb Tampa facility.
Primarily responsible for all activities associated with cGMP compliance including incoming quality, laboratories, documentation, training, auditing, manufacturing quality and validation oversight.
Directs operational support associated with product transfers, product optimization, product maintenance, and key studies associated with product or analytical investigations.
Most responsible Quality person at the Tampa site, approving and implementing major changes that require financial investment, the ability to hire and fire employees, the ability to spend money, and the responsibility to correct GMP deficiencies.
Responsibilities:
Responsible for the assessment and disposition of all purchased and produced materials.
Responsible for the management of product and process quality information and the identification of relevant trends, with emphasis on prevention and proactive management of potential future issues, as well as capturing improvement opportunities.
Direct all activities of the Marketed Stability Program, with specific emphasis on robustness of formulation and analytical methods.
Responsible for the periodic assessment of product quality performance through Annual Product Review Program.
Responsible for the management of all aspects of the site cGMP documentation system.
Key role in the technical transfer of analytical methods and specifications for new products from R&D to Operations/QA.
Responsible for retention of Control Records for purchased and produced products.
Responsible for the assessment and disposition of returned products.
Responsible for the product complaint handling system.
Responsible for oversight of all validation/qualification activities in support of new product development, equipment, facility, and ongoing critical systems necessary for the compliance of commercial product.
Directs activities related to any market actions.
Reports on compliance status of B&L facility to Management on a regular basis.
Coordinates preparation for and is the key person responsible for all activities related to inspections by regulatory agencies and third parties.
Responsible for continuous assessment of the regulatory compliance environment (new regulations, guidance's, Warning Letters, etc.) and its impact on B&L taking appropriate action.
Directs the investigations and troubleshooting of on-line process and analytical issues with potential resolutions to appropriate decision-making boards.
Systematic evaluation and improvement of procedures and processes of all ongoing manufacturing processes.
Provides technical support to key operational and regulatory management. Responsible for the departmental compliance of applicable FDA, OSHA (safety) and EPA (environmental) regulations.
Support EHS&S initiatives.
Requirements:
Bachelor of Science degree
Minimum 12 years of experience in the pharmaceutical field with aseptic solution experience/exposure.
Minimum 8 years in Quality with leadership experience, ideally with QA and QC experience.
Must possess strong leadership and time management skills.
Must be able to read, write, and speak English and possess basic math skills.
We offer competitive salary & excellent benefits including:
Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
401K Plan with company match and ongoing company contribution
Paid time off - vacation (3 weeks - prorated upon hire), floating holidays and sick time
Employee Stock Purchase Plan with company match
Employee Incentive Bonus
Tuition Reimbursement (select degrees)
Ongoing performance feedback and annual compensation review
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Bausch+Lomb's Job Offer Fraud Statement .
Our Benefit Programs:
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.
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