Please note that due to the COVID-19 pandemic, this position is currently remote however once we return to the office this position will be based in Durham, NC.
We seek a highly motivated, detail-oriented individual for a Validation Quality Assurance Specialist role with Nuventra Pharma Sciences.
Lead software/system validation efforts
Responsible for qualifying new systems, maintaining the qualified state of existing systems including computerized systems and equipment
Responsible for writing, executing, and summarizing validation protocols, leading the development and maintenance specification documents, traceability matrices, and assisting in the development of validation plans
Analyze and summarize periodic reviews of previously validated systems and to develop and implement protocols/changes based on the outcomes of those reviews
Assist user groups in troubleshooting and analyzing of systems and lead the resolution of deviations noted during a systems lifecycle
Provide direction, support, and oversight for both internal and external contract validation resources
Ensure that relevant and compliant documentation is generated, executed, and summarized as required, by site SOP, company policy, and international cGxP regulations with some supervision
Maintaining validation system inventory
Assist in the quality review of documents (format and quality based on company SOPs)
Support ongoing quality programs and initiatives, and other duties as assigned
Contribute to the generation and review of required documentation (such as SOP’s, protocols) to support the validation lifecycle requirements
Support other functional areas of the company with document management duties, including scientific, business operations, legal, etc.
BA/BS, preferably in a science and/or computer science related field along with 1-5 years of relevant experience.
The ideal candidate will have an exceptional attention to detail, a strong drive for maintaining consistent processes, good communication skills, and must have the ability to work in a team setting as well as independently with minimal supervision.
Some experience in FDA 21 CFR Part 11/GAMP 5 would also be desirable.
Benefits and Perks:
Great Medical, Dental, and Vision plans (Vision is covered 100% for all employees and their families)
401(k) and student loan matching
Flexible work environment including weekly remote work options
Paid childbirth and childcare leave
Paid 5 week sabbatical after 5 years of employment
Stocked kitchen with drinks, goodies, and snacks
Frequent company and team-building events
Monthly gym reimbursement
8 hours of paid volunteer time-off
Diversity is a key to success. We are an equal opportunity employer and welcome applicants of all backgrounds, experiences, and perspectives.