The Senior Specialist, Quality Assurance Validation will be responsible for supporting Quality Assurance and Operations functions with an emphasis on Commissioning, Qualification, and Validation. They will provide oversite and direction for all elements of the Validation program including the development of procedures, templates, and training. They will act as the liaison and subject matter expert to support internal teams and vendors as they author and execute validation-related documentation (for equipment, processes, computer systems and methods), providing review and final approval. They will also help author and execute select validation documents to aid the site as needed.
Key Areas of Focus
- Uses Vernal’s quality systems and programs to promote high-quality standards and continuous quality improvement.
- Work with internal teams and vendors to help develop sound requirements and robust testing, being responsible for the Quality Assurance approval on validation-related documents.
- Provides guidance and counsel regarding data integrity and utilizes knowledge to further data governance at Vernal.
- Review vendor-provided documentation, noting gaps that require further testing.
- Utilize the electronic Quality Management System (eQMS) to manage elements of the Validation program (templates, forms, schedules).
- Ensures compliance with FDA Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP), EU, and ICH guidelines and regulations concerning all elements of Validation within Vernal (equipment, processes, computer systems, and methods).
- Provides back-room support for health authority inspections and customer audits.
- Ensures documentation is compliant with Vernal SOPs, formats, and regulatory requirements (protocols, amendments, etc.)
- Authors and reviews validation-related SOPs. Reviews all Vernal’s SOPs to ensure appropriate codification of GCP/GMP procedures relating to product quality and quality compliance systems.
- Responsible for developing and providing training for validation-related activities.
Essential Duties and Responsibilities
- Support quality policy, mission, and vision.
- Provide Validation and Quality Assurance expertise to cross-functional teams.
- Support the development, documentation, communication, implementation, measurement, and continuous improvement of the systems that make up the overall Vernal Quality System, with emphasis on all elements of Validation.
- Ensure the Vernal Quality System follows applicable federal, state, local, and customer quality requirements (signed QTA).
- Represent the Quality organization in internal discussions.
Professional Experience and Qualifications
- Bachelor’s degree in a scientific or engineering discipline or equivalent experience required.
- 3-5 years in a role familiar with the quality organization, validation preferred.
- GCP/GMP experience in a biotech, pharmaceutical or clinical research organization is beneficial
- Demonstrated ability to participate in cross-functional teams.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, and escalate needs to meet critical timelines.
- Experience in implementing, monitoring, and improving corporate-wide quality systems.
- Basic knowledge of GCP, GLP, ICH guidelines, FDA guidelines, and other applicable regulatory requirements.
- Understanding of GAMP and Qualification Baseline Guides.
- Experience with validation execution, including computer system validation and temperature mapping, preferred.
- Excellent organizational, verbal, and written communication skills.
- Demonstrated ability to problem-solve and learn.
How to Apply
If you feel that you are a great match for this position and want to make a difference in the exciting field of next-generation therapeutics, then reach out to us at [email protected] and be sure to include your resume and cover letter as well as the job title in the subject line. We look forward to hearing from you!
Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture.
At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA. Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D. Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials. The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA. As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency. We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business. Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance. Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.
Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center. Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:
- Multicultural hub with great schools, restaurants, breweries, shopping, arts, and an affordable cost of living
- Gateway to the Green Mountains including world class hiking, camping, bicycling, and alpine and Nordic skiing