QA Lead- Supervisor

August 23

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GreenLight Biosciences

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A mission-driven biotech using the power of RNA to tackle some of humanity's greatest challenges.

201 - 500

💰 $109M Post-IPO Equity on 2022-08

Description

• The GreenLight team is looking for a self-motivated individual who works well in a fast-paced environment to play a pivotal role building a GMP compliant manufacturing facility to advance is product into the veterinary medicine marketplace. • The candidate will assist with creation of QMS systems and governing SOPs as well as the review of executed documents (i.e., batch records, validation protocols, etc.). • Additional responsibilities will relate to activities supporting contract manufacturing quality oversite.

Requirements

• Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management. • Non-degreed candidates with 10+ years combined of relevant GLP/GMP quality systems experience will be considered. • 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 be able 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 to include regulatory agency inspections. • Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a collaborative and engaged environment. • 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. • Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels. • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges. • Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).