Team Lead VI

Bausch & Lomb GmbH; Greenville (SC); On-site; USD 52,000 - 76,000; Full time

Job summary

Bausch + Lomb in Greenville, SC is seeking a quality assurance professional to safeguard product quality and batch records from the manufacturing rooms. This role provides site-wide quality oversight and serves as the on-shift contact for manufacturing issues, requiring critical thinking and decisive action.

You will review batch documents, ensure GMP/GDP compliance, assist investigations, perform CAPA verifications, and help implement process improvements while maintaining data integrity and

Qualifications

• Demonstrated understanding of GMPs and quality system regulations.
• Detail oriented, well organized, and the ability to multi-task and shift priorities when needed to meet operational requirements and customer demand.
• Ability to elevate and solve shop floor issues per procedures and utilize analytical and critical thinking skills.

Responsibilities

• Quality oversight for the manufacturing shop floor with daily walkthroughs and documentation checks.
• Review and approval of batch records and quality oversight documentation.
• Ensure GMP/GDP compliance and ALCOA data integrity across areas of oversight.
• Assist with investigations, root cause analysis, and CAPA effectiveness verifications.
• Support process improvements and manufacturing schedules.

Skills

Detail oriented

Well organized

Multi-tasking

Critical thinking

Job description

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Bausch + Lomb (NYSE/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.

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. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. 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/Purpose of Job:

The assurance of quality product and batch records from the manufacturing departments. Evaluates quality issues with Manufacturing and Quality Assurance and provides quality oversight across the site.

Key Activities/Responsibilities:

• Quality oversight for the manufacturing shop floor. Responsible for daily area walkthroughs and documentation spot checks. Point of contact during off shift hours for any manufacturing issues. Critical thinking and decision-making ability is required. Ability to determine when to elevate issues to site leadership immediately versus providing notification of an event.
• Create and revise quality related documentation. Review and approval of records for various areas of quality oversight.
• Follows standard operation procedures and batch records to ensure compliance with Good Manufacturing Practices (GMP) and ensures areas maintain data integrity and proper Good Documentation Practices (GDP), including ALCOA.
• Evaluates quality issues and assists with the investigations, providing necessary information and documentation when needed. Assist/perform failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Execute CAPA effectiveness verifications to confirm that the corrective actions implemented are effective.
• Assist in implementation of process improvements.
• Monitor and conduct in process inspections in the manufacturing area, implementing proper documentation practices, applicable visual inspections, testing intervals and/or methods, as per batch record instructions and current SOP.
• Properly identifies suspect material and performs segregation procedures, or per provided written instructions.
• Check batch documents to ensure product, lot number, expiration dates and all components are correct, and conducts online reviews.
• Performs AQL sampling and documents inspection results in the batch record.
• Performs product inspections, and line clearance duties per procedures.
• Interacts with other departments including Receiving Inspection, Materials Management, Contract Manufacturing, Engineering, Validation, and Quality Control laboratories. Assists and executes protocols and studies.
• Assist the manufacturing team with the issuance, correction and review of batch documents.
• Assist Manufacturing team as needed with batch record reviews and batch record closure on each line at the end of the run including accountability and yield calculations.
• Completes all required documentation review and work with the Manufacturing team to resolve outstanding issues before releasing to Quality Assurance.
• Quality oversight of validation activities for various areas of oversight.
• Supports and actively participates in standardization and Quality metrics.
• Support of manufacturing schedules and changes.
• Assume the responsibility for the GxP, ISO, and environmental health and safety procedure awareness and compliance within the respective area.
• Maintain compliance to GxP and procedural reading; personal development.

All other duties as assigned.

Qualifications/Training:

• Demonstrated understanding of GMPs and quality system regulations.
• Special Skills: Detail oriented, well organized, and the ability to multi-task and shift priorities when needed to meet operational requirements and customer demand. Ability to elevate and solve shop floor issues per procedures and utilize analytical and critical thinking skills.

Eligibility for Internal Applicants:

Have no corrective actions at the written warning level in last six months / no final warning level in the last 12 months / no active PIP.

Meet the qualifications of the position as stated above.

Be in your current job for 12 months.

Position applying for must be a step up in progression and not a step down.

Schedule: Saturday & Sunday 7am-7pm and two days during the week

This position may be available in the following location: Greenville, SC

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.

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.