Quality Assurance Specialist Lead

Position summary:

The GreenLight team is looking for a self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. The company is looking for a key individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. Reporting directly to the QA Director, the individual will be a key contributing member of our Human Health program team. The candidate will assist in maintaining the document control system, assist in establishing and maintaining some key aspects of the QMS system and additional responsibilities related to day to day to support the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will have experience in both document control support and quality systems in a regulated industry setting (e.g., FDA GLP / cGMP).  Candidates with either paper-based and /or electronic (e.g., Veeva, etc.) system experience will be considered. 

RESPONSIBILITIES:

• Responsible for the administrative oversight of the electronic quality management system, Veeva, including:
  • Review and approve Quality system and batch related documentation (e.g., cGMP procedures, batch records, solution records, QC testing, Certificates of Analysis, protocols, and reports, etc.)
  • Review and approve GMP raw data for compliance.
  • Provide assurance that the Quality Management System elements (CAPA’s, Deviations, Change Control) are well defined in procedures and followed.
• Provide Quality Assurance support to cross functional teams including, but not limited to, Manufacturing, Engineering and Quality Control departments.
• Provide training to GreenLight team members on the importance of good documentation practices and GMP to ensure successful business outcomes.
• Provide mentoring and training to staff that are new to regulatory requirements, to facilitate the use of established quality system.
• Collaborates with internal and external stakeholders to ensure that regulatory agency quality assurance requirements are met.
• Participate in Regulatory inspection or other audits, as required.
• Quality oversight of manufacturing product changeover.
• Perform duties regarding special projects, as assigned by QA Management.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

• Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 4+ years combined of experience in documentation and quality system management.
  • Non-degreed candidates with 8+ years combined of relevant GLP/GMP document and quality systems experience will be considered.
• Self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
• Thorough knowledge of applicable GLP / GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU).
• General understanding of phase appropriate Quality concepts and requirements; and be able to practice and implement them.
• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
• Experience with creating documentation such as Standard Operating Procedures (SOPs), Work instructions, Batch Records etc.
• Experience initiating and completing quality management system elements such as change control, deviations, CAPAs, and Nonconforming Material Reports.
• Electronic document management system experience preferred along with the ability to create / conduct training sessions.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.
• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).