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.

Responsibilities:

  • 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.

Qualifications:

  • 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.

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