Quality Assurance Specialist

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 5 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