Specialist, Quality Assurance Jobs

The Specialist, Quality Assurance will be responsible for supporting Quality Assurance and Operations functions. He or she will provide administrative oversite of the electronic quality management system (eQMS, Master Control). He or she will act as the liaison and subject matter expert to support internal teams as they access master control for authoring, reviewing, approving, training, and other capabilities of the electronic quality management system.

Key Areas of Focus

• Uses Vernal’s quality systems and programs to promote high-quality standards and continuous quality improvement
• Provides back-room support for health authority inspections and customer audits
• Provide administrative support for the electronic quality management system (Master Control)
• Provides guidance and counsel regarding the use of eQMS.
• Reviews all Vernal’s SOPs to ensure appropriate codification of GCP/GMP procedures relating to product quality and quality compliance systems
• Ensures documentation is compliant with Vernal SOPs, formats, and regulatory requirements (protocols, amendments, etc.)
• Responsible for training program including on-the-job training for manufacturing, release testing, and on SOPs, regulatory requirements, and quality initiatives
• Ensures compliance with FDA Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP), EU, and ICH guidelines and regulations concerning the use of eQMS within Vernal.
• Work with the eQMS vendor to ensure updates are compliant and maintain the validated state of the electronic quality management system.

Essential Duties and Responsibilities

• Support cross-functional teams during activities that support GMP manufacturing, including but not limited to writing or reviewing documents, executing validation protocols, performing internal audits, and supporting client audits, releasing materials and equipment, and performing gowning qualification.
• Support quality team during the establishment of the electronic quality management system.
• Demonstrate an enthusiasm for learning and working collaboratively across all departments.
• Support the development, documentation, communication, implementation, measurement, and continuous improvement of the systems that make up the overall Vernal Quality System
• Support quality policy, mission, and vision.
• Ensure the Vernal Quality System follows applicable federal, state, local, and customer quality requirements (signed TQA)
• Represent the Quality organization in internal discussions.
• Provide eQMS support to cross-functional teams

Desired skills and background

• Demonstrated ability to problem-solve and learn.
• Experience in implementing, monitoring, and improving corporate-wide quality systems.
• Bachelor’s degree in a scientific or engineering discipline or equivalent experience required.
• Demonstrated ability to work independently, handle multiple tasks simultaneously, and escalate needs to meet critical timelines.
• GCP/GMP experience in a biotech, pharmaceutical or clinical research organization is beneficial
• Demonstrated ability to participate in cross-functional teams.
• 0-5 years in a role familiar with the quality organization.
• Basic knowledge of GCP, GLP, ICH guidelines, FDA guidelines, and other applicable regulatory requirements.
• Excellent organizational, verbal, and written communication skills.

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. We look forward to hearing from you!

Diversity/Equal Opportunity

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: