Quality Assurance Specialist

ABOUT GREENLIGHT

GreenLight Biosciences is using RNA to create a world where plants, people, and the planet can thrive together. The company is developing highly effective agricultural solutions for farmers and beekeepers that are targeted to specific pests and degrade quickly in the environment. Our pipeline includes products to protect honeybees and a range of fruits and vegetables. The GreenLight platform allows us to research, design, and manufacture across multiple product categories including insecticides, fungicides, and herbicides.

For more information, visit www.greenlightbio.com.

GreenLight Biosciences is a company who develops and manufactures RNA based products for sustainable crop

protection solutions using a cell-free bioprocessing technology platform. The GreenLight team is looking for a self-

motivated individual who works well in a fast-paced environment to play a pivotal role in building a GMP

compliant manufacturing facility to advance is product into the veterinary medicine marketplace.

Duties and Responsibilities

· Review and approve quality system and batch-related documentation, including, but not limited to, SOPs,

batch records, protocols, validation reports, and Certificates of Analysis.

· Support the creation and implementation of QMS documentation

· Provide Quality Assurance support across cross-functional teams including Manufacturing, Supply Chain,

Engineering, Distribution, Contract Manufacturing, and Quality Control, with a focus on adherence to

batch records and GMP procedures.

· Ability to initiate and support the management of CAPAs, deviations and investigations as well as monitor

completion of such quality compliance activities.

· Support process improvements to enhance compliance and product quality processes

· Perform duties regarding special projects, as assigned by Quality Management.

· Participate in internal and external audits, including regulatory inspections. Support audit readiness and

documentation accuracy.

· Identify and resolve compliance issues and quality gaps. Initiate and manage CAPAs, deviations, and

investigations in accordance with GMP expectations.

· Additional responsibilities will relate to activities supporting contract manufacturing quality oversite.

· Oversee equipment status including calibration, maintenance, validation, and change control activities.

· Collaborate with internal and external stakeholders to ensure adherence to regulatory quality assurance

requirements.

Education and Qualifications

· Bachelor’s degree in a scientific or operational discipline relevant to life sciences or biopharma required.

This role may also be filled with non-degreed employee with 10+ years of relevant GLP/GMP quality

systems experience.

· Minimum of 3 years of combined experience in quality system management.

· Familiarity with global cGMP and ISO regulations, particularly those related to veterinary medicinal

products, is a plus.

Required Skills

· Strong understanding of GLP/GMP regulations, ICH and FDA guidelines, and quality system principles.

· Demonstrated ability to analyze data, plan and implement improvements, and communicate effectively in

a collaborative environment.

· Skilled in documentation review, audit participation, and deviation/CAPA management.

· Excellent interpersonal and communication skills, with the ability to influence, negotiate, and resolve

challenges.

· Self-motivated, detail-oriented, and capable of working independently and within a team.

· 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.

· Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook, Teams).

Working Conditions

· Work is primarily performed in an office setting with regular access to GMP controlled environments.

· Requires adherence to gowning procedures and PPE requirements when entering controlled areas.

· Occasional standing, walking, and observation of production or quality control activities may be required.

· May involve participation in audits, inspections, and walkthroughs in controlled or warehouse

environments.

· Requires use of computer systems for documentation, training records, and quality system management.

· Flexibility to support off-shift or weekend activities during audits, investigations, or urgent quality events.

Salary Range: $80,000-$105,000

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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.