Quality Assurance Manager

3 days ago

Rochester, New York, United States Greenlight Biosciences Full time
About GreenLight Biosciences

GreenLight Biosciences is a pioneering company that leverages RNA technology to create innovative agricultural solutions for farmers and beekeepers. Our mission is to develop highly effective products that protect honeybees and a range of fruits and vegetables, while degrading quickly in the environment.

Job Title: QA Lead-Supervisor

We are seeking a highly motivated and experienced Quality Assurance Lead-Supervisor to join our team in Rochester, NY. As a key member of our manufacturing organization, you will play a pivotal role in building a GMP compliant manufacturing facility to advance our products into the veterinary medicine marketplace.

Key Responsibilities:
  • Create and implement standard operating procedures, protocols, and reports to ensure compliance with regulatory requirements.
  • Review and approve quality system and batch-related documentation, including cGMP procedures, batch records, QC testing, and certificates of analysis.
  • Initiate and support the management of CAPAs, deviations, and investigations, as well as monitor completion of quality compliance activities.
  • Provide Quality Assurance support to cross-functional teams, including Manufacturing, Warehousing, Distribution, Contract Manufacturing, and Quality Control departments.
  • Mentor and train staff on regulatory requirements and established quality systems.
  • Collaborate with internal and external stakeholders to ensure regulatory agency quality assurance requirements are met.
  • Oversight of equipment status, including calibration, maintenance, validation, change control, and product changeover.
  • Participate in regulatory inspections and audits, as required.
  • Identify potential compliance issues and opportunities for improvement to the overall Quality System.
  • Implement process improvements to enhance compliance and improve methods and product quality processes.
Requirements:
  • Bachelor's degree in a scientific or operational discipline relevant to the life sciences or biopharma areas, with 5+ years of combined experience in quality system management.
  • Thorough knowledge of applicable GLP/GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU).
  • Familiarity with global cGMP and ISO regulations relating to veterinary medicinal products is a plus.
  • Understanding of Quality concepts/requirements and ability to practice and implement them, as well as GMP Manufacturing processes.
  • Experience creating/reviewing/approving documentation, such as Standard Operating Procedures (SOPs), Work instructions, Batch Records, protocols, etc.
  • Experience with performing audits and participating in audits, including regulatory agency inspections.
  • Excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
  • Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).

Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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