Specialist, Quality Assurance

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:
o Medical Devices
o Packaged/Labeled Medical Devices
o Clinical Product
o 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, la...