Quality Assurance Specialist I

Bausch & Lomb GmbH; Greenville (SC); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Bausch + Lomb seeks a Quality Assurance Specialist I to support manufacturing and distribution at the Greenville, SC site. The role covers the product life cycle from design input through post-launch maintenance, ensuring adherence to quality systems and regulatory standards.

Responsibilities include investigations of nonconformances, CAPA execution, trend analysis, and validation document reviews to sustain continuous improvement in a GMP environment.

Competenze

• Bachelor's degree in life sciences, physical sciences, engineering, or related field.
• Certifications such as CQA, CQE, or CQM preferred.
• Experience in Quality Assurance or Quality Control within pharmaceutical or medical device manufacturing.
• Familiarity with 21 CFR 210, 211, and ISO 13485.
• Strong GMP knowledge and regulated quality systems.
• Experience with nonconformance investigations and root cause analysis.

Mansioni

• Participates in efforts with manufacturing and engineering to improve product and process quality.
• Ensures decisions are based on quality principles and regulatory guidelines.
• Manages nonconformances and assists with root cause analysis and CAPA verification.
• Trends key quality metrics and prepares reports for management.
• Reviews validation activities and related documentation.

Conoscenze

Detail-oriented

Multi-tasking

Formazione

BA/BS in life sciences

Descrizione del lavoro

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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 role of Quality Assurance Specialist I is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Assurance Specialist I may be involved in all stages of the product life cycle -Product design, manufacturing support, and post-launch maintenance.

Key Activities:

• Participates in efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.
• Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
• Management of nonconformances for assigned areas of QA oversight. 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.
• Trending of key quality metrics, including nonconformances. Preparation of trend reports and presentations for management. Evaluate metrics to identify areas of potential process improvement. Assist in implementation of process improvements.
• Quality oversight of validation activities for assigned areas of oversight, including QA review and approval of validation documentation.
• Create and revise quality related documentation. Review and approval of operations records for assigned areas of quality oversight.

Qualifications:

• Bachelor's degree (BA/BS) in life sciences, physical sciences, engineering, or a related field is required.
• Certifications preferred: CQA, CQE, and CQM.
• Experience in Quality Assurance or Quality Control within pharmaceutical or medical device manufacturing.
• Familiarity with 21 CFR 210, 211, and/or 820 and ISO 13485.
• Strong understanding of GMPs and regulated quality systems Experience:
• Experience with nonconformance investigations and root cause analysis preferred Ability to trend, analyze, and graph data for presentation to management

Special Skills:

• Detail-oriented and well-organized
• Ability to multi-task and effectively shift priorities as needed to meet operational requirements and customer demand

This position may be available in the following location(s): US - Greenville, SC (Plant)

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.