Quality Software Specialist - Bausch + Lomb : Job Details

This position will perform basic administrative functions of QC Laboratory instruments at Tampa site to assure compliance with cGMPs/GLPs/GAMP/FDA, 21 CFR Part 11, Data Integrity, and Regulatory guidelines/requirements. This role will provide compliance oversight for the QC Laboratory software systems installed at the Tampa site.

Key Activities/Responsibilities:

• Act as system administrator for local QC Laboratory software systems.
• Continuously monitor and maintain basic operation of QC Laboratory software and related analytical instruments to minimize downtime and improve reliability.
• Maintains compliance of software applications such as Data Integrity, backups, archive, user management, audit trail, as applicable.
• Create, remove, deactivate, modify user accounts within QC Laboratory software systems.
• Performs system user access review and system audit trail review.
• Supports QC Laboratory operations on day-to-day operations.
• Assist with regulatory audits/inspections.
• Completes assigned tasks to support Change Management, NC/CAPAs, Validation, or similar requirements.
• Supports the development or revision of applicable software related procedures.
• Responsible for ensuring basic functional aspects of QC Laboratory software.
• Solves routine problems of limited scope and complexity by following established policies and procedures.
• Participates and supports projects related to software application changes and upgrades.
• Complete assigned testing of basic function to support software validation.
• Participate in continuous improvement projects.
• Supports completion of validation & requalification tasks.
• Perform all other tasks, projects, and duties as assigned.

Qualifications/Training:

BS Chemistry, BS Engineering, BS Computer Science, or related software applications experience. Must be able to read, write, and speak English and possess basic math skills. 0-2+ years. Basic knowledge of cGMP regulations. Basic Empower operations and administrator knowledge. Basic GLIMS operations and administrator knowledge. Basic LabVantage knowledge. Limited use and/or application of basic laboratory software principles, theories, and concepts. Basic knowledge of industry practices and standards. Basic knowledge of software validation requirements.

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. 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. To learn more please read Bausch + Lomb's Job Offer Fraud Statement. 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.