Quality Assurance Specialist I- CAPA

Bausch + Lomb•US-SC-Greenville, SC

5d•Onsite

About The Position

Bausch + Lomb is a global eye health company focused on protecting and enhancing sight. The Quality Assurance Specialist I - CAPA role reports to the Manager, Quality Systems & Compliance (QSC) and serves as the CAPA coordinator for the site. This position is responsible for executing routine Quality System tasks and leading/executing Quality System improvement projects. The role involves ensuring timely closure of CAPA activities, conducting internal audits, supporting regulatory inspections, and writing/reviewing procedures. It also requires providing oversight for quality system elements, working with various departments on investigations and root cause analysis, and acting as a liaison between customers and operations/quality. The specialist will manage the CAPA system and associated board, promote communication, and lead projects to enhance quality systems. Additionally, the role involves maintaining and improving quality documentation and investigations, writing and reviewing SOPs, and supporting the Quality System Compliance Department.

Requirements

Bachelor's degree in a scientific, engineering, or other technical discipline required.
Proficiency with database applications, including Microsoft Excel and Microsoft Access.
3+ years of Quality Assurance experience in an FDA-regulated manufacturing or distribution environment required.
Demonstrated technical writing and documentation skills.
Strong analytical and critical thinking abilities.
Ability to effectively communicate and build relationships with employees at all levels of the organization.
Strong organizational skills with the ability to manage multiple priorities and work independently with minimal supervision.
Excellent verbal and written communication skills, including the ability to effectively interact with cross-functional teams and customers.
Excellent time management and project prioritization skills.
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.

Nice To Haves

Specialized training in 21 CFR Part 211, 21 CFR Part 820, ISO 9001:2000, and ISO 13485 preferred.
Experience with quality management systems/databases such as D2 and CQMS preferred.
Experience in pharmaceutical (drug) or medical device manufacturing preferred.
Strong understanding of CAPA processes and quality system requirements, with the ability to identify root causes, evaluate corrective actions, and drive timely closure of CAPA records highly preferred.
Experience conducting internal or external quality audits preferred.
Experience leading or participating in quality investigations and root cause analysis preferred.

Responsibilities

Coordinates CAPA related activities to ensure timely closure and effective plans.
Conducts internal audits as needed.
Supports regulatory and third-party inspections for the site.
Interfaces with outside regulatory and legal authorities as appropriate.
Write, review, revise and approve procedures and specifications, as needed.
Provide oversight for various quality system elements and tools.
Works with quality, operations, distribution to ensure sound and timely decisions/investigations are made/written regarding nonconformance and root cause, CAPA analysis.
Acts as a liaison between retail customers and operations / quality.
Manage the CAPA system and associated CAPA board.
Promote open communications within the site and with external contacts.
Lead and execute various projects to enhance the site’s quality systems.
Provide quality systems assistance for site functions.
Review/approve investigation reports.
Maintain and continually improve quality documentation and investigations.
Write and review SOPs with a focus on improved content.
Contribute to QPI improvement activities.
Additional activities to support Quality System Compliance Department as needed.