Director of Quality Job at Vestaron, Durham, NC 27703

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Job Description

Vestaron is leading a peptide-based revolution in crop protection. The company is dedicated to improving the safety, efficacy and sustainability of crop protection through migration from chemical pesticides to biological peptides. Vestaron’s peptides provide growers with novel crop protection solutions that address proven targets and provide efficacy on par with or better than traditional chemical pesticides. Its peptides overcome existing resistance issues while offering a desired safety profile for workers, beneficials and the environment. Vestaron has earned global recognition for its work, including the inaugural 2015 Bernard Blum Award for a novel biocontrol solution, the prestigious Green Chemistry Challenge Award from the U.S. Environmental Protection Agency in 2020 and “Best New Biologic Product” at the 2021 IHS Market Crop Science Awards.

The Opportunity:

Vestaron is currently recruiting a Director of Quality to join our team in Research Triangle Park, NC reporting to Vice President of Operations. The Director of Quality will be responsible for designing, implementing, and managing Vestaron's quality assurance and control programs. The Director of Quality will have oversight of the quality labs (analytical and microbiological) located in Research Triangle Park.

Responsibilities:
  • Coordinate with department managers to develop, write, review, and approve SOPs and product specifications for the Operations group and ensure documents are compliant with Vestaron Regulatory.
  • Review documents or materials for compliance with cGMP policies and regulations.
  • Devise testing plans and methods to improve Vestaron product quality from raw materials to customer.
  • Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends and working with internal teams to understand trends.
  • Develop, implement, and manage the company's quality management program.
  • Develop quality assurance plans by conducting hazard analyses, identifying critical control points/preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures.
  • Maintain batch record traceability and Certificate of Analysis (CoA) for all batches of tested bulk and finished products.
  • Maintain all specifications for product testing and release.
  • Manage analytical method development, method transfer/validation for analytical testing.
  • Ensure standardized tests on products meet standards and regulations regarding factors including but not limited to: labeling compliance, product quality, consistency and other factors such as chemical composition.
  • Lead operational communications for qualifications, complaints, and audits. Communicates key quality information to appropriate internal personnel.
  • Manages daily quality activities including supervision & development of QA personnel, control of non-conforming products, quality inspection & traceability records, measurement systems analysis, QA training records, and lot inspection.
  • Ensures product quality and processes adheres to specifications and manufacturing requirements. Takes corrective actions to cure specification deficiencies and manage the deviation process until specification issues are resolved.
  • Coordination and implementation of Change Management process
  • Ensure finished products meet labeling standards including compliance with EPA regulations for pesticides, ingredients, limitations on product claims, disclaimers, and warnings.
  • Review batch records and associated documentation. Lead internal investigations and manage CAPA (Corrective Action Preventative Action) program.
  • Responsible for supplier qualifications/audits, vendor selection audits, and all regulatory inspections.
  • General oversight of facility recordkeeping.
  • Other duties as assigned.

Requirements:
  • BS or equivalent required, master's level degree in the physical sciences preferred.
  • QA experience in Pesticide industry/pharmaceuticals over 8 years is required with at least 3 years of those at management capacity and project management skills.
  • Strong knowledge and experience of EPA, cGMP, TSCA, USDA and International regulations and auditing techniques.
  • Experience in analytical testing methods for potency, residual solvents, and pesticides including but not limited to HPLC and LC-MS.
  • High level of interpersonal skills, strong leadership abilities, organizational and time management skills.
  • Familiarity with fundamental microbiology and microbiological techniques is a plus
  • Excellent communicator.
  • Ability to work independently and meet deadlines.
  • Willing to travel up to 15-20%.

Why Join Us?

Join the Revolution…
With an innovative and accomplished leadership team guiding our day-to-day wins, and a Board with a long-term vision that supports our efforts, we set out daily to improve the safety, efficacy and sustainability of crop protection through migration from synthetic pesticides to peptide-based biopesticides. Our team is empowered to solve problems and find solutions that will advance the science and commercialization of peptides. If you’re seeking a career that taps into your talents and contributes to harnessing the Power of Peptides® for the benefit of the environment and industry, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that.

In 2019 we opened our headquarters in the heart of RTP (Research Triangle Park, NC), a global center of Agricultural Technology and Innovation. Our lab is located on Stirrup Creek Drive, near a vibrant work environment with restaurants, shops and hotels. Our R&D center is in Kalamazoo, MI, within the Western Michigan University Innovation Center. The 69,000-square-foot, purpose-built incubator and co-working space was created to support companies from the earliest start-ups to maturing organizations with office and conference space, high-quality shared scientific equipment and resources, and a wide range of support services.

We offer a competitive benefits package, to support the health and happiness of our staff. We invite you to apply to join a company developing the products, processes, and relationships to lead the advancement of the biological peptide industry, beginning with the pesticide markets.

An Equal Opportunity Employer
Vestaron is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Vestaron are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

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