LCI · 16 hours ago
Specialist, Quality Assurance
Durham, NC
Full-time
Onsite
Mid Level
3+ years expLCI is dedicated to providing meaningful employment for the blind and visually impaired. The Specialist, Quality Assurance is responsible for ensuring compliance with laws and regulations through the performance of Batch Record Review and Disposition functions, as well as managing activities related to GMP document review and oversight of third-party contractors.
EmploymentManufacturingRetail TechnologyWholesale
Responsibilities
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
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
Qualification
Required
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
Benefits
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)
Company
LCI
LCI is a provider of manufacturing, distribution, wholesale, retail and technology consulting solutions – and one of the largest employers of Americans who are blind or visually impaired.
501-1000 employees
H1B Sponsorship
LCI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$400M2025-03-11Post Ipo Debt· $400M
1985-05-31IPO
Leadership Team
Patrick Lindsey, CPA
Chief Operating Officer
Recent News
24-7 Press Release Newswire
2025-11-09
2025-11-07
2025-11-04
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