ABOUT LCI

The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways:

• EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives.
• BUILD: We create over 2, 000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels.
• SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers, ” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation’s military.
• SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired.

ABOUT THIS ROLE

The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products.

LOCATION AND SCHEDULE

Durham, NC

Monday-Friday 8: 30 AM – 5 PM

KEY RESPONSIBILITIES

• Batch Review and disposition:
  • Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches.
  • Review and approve Master Batch Records.
  • Perform the review of records and determine disposition of:
    • Medical Devices
    • Packaged/Labeled Medical Devices
    • Clinical Product
    • Investigations and CAPAs.
  • Perform the review of Testing Specifications.
• Validation
  • Coordinate and monitor validation activities.
• Provide support during regulatory inspections of GMP Contractors and LCI facilities.
• Assist in performing inspection readiness activities.
• Review Quality Agreements.
• Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry.
• Provide updates to Manager, BioMed Operations.

QUALIFICATIONS

• Bachelor’s Degree in a life science-related discipline or equivalent work experience.
• Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation.
• Experience in working with third-party contract manufacturers, laboratories, and packagers.
• Knowledge of pharmaceutical industry regulatory requirements.
• High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions.
• Ability to exercise strong risk-based business judgment.
• Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization.
• Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality.
• Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally
• Good investigation and monitoring skills.
• Current knowledge of QC testing methods.
• Attention to detail and implementation of good documentation and GMP processes is essential.
• Excellent communication skills required and must be computer literate.
• Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations.

Why LCI?

• Purpose-driven company driven by principles, not profit
• Reach your highest potential: upward mobility, rewarded through hard work
• Competitive salary and compensation
• Basic Life Insurance at no cost to the employee
• 401(k) with match and Surplus-Sharing Plans
• Health, Dental, and Vision Insurance
• Ten paid holidays annually
• Paid Time Off (PTO)
• On-site Health and Wellness program
• Employee Assistance Program (EAP)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.