Overview
Software Quality Assurance Engineer Jobs in East Hartford, CT at CS Group
About Forge
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About The Role
We are currently seeking a Quality Assurance Operations Specialist join the Forge Biologics Team. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. The Specialist will provide expert support to the Quality Assurance team in activities such as document control, batch record review, deviation management, internal and external audits, training, and continuous improvement initiatives specific to AAV gene therapy manufacturing.
What You’ll Do
Lead and manage the document control process for AAV gene therapy manufacturing, ensuring compliance with regulatory requirements, industry best practices, and internal quality standards.
Conduct detailed review and approval of complex batch records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations.
Provide expert guidance and support in the investigation of deviations and non-conformances related to AAV gene therapy manufacturing processes, performing in-depth root cause analysis and implementing effective CAPA measures.
Plan and execute internal audits of AAV gene therapy manufacturing activities, leading audit teams, assessing compliance with cGMP regulations and quality systems, and driving corrective and preventive actions.
Prepare and participate in external audits and inspections, ensuring successful outcomes and addressing observations or findings related to AAV gene therapy manufacturing.
Develop and deliver comprehensive training programs for manufacturing personnel on quality-related topics, ensuring consistent understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
Lead and support cross-functional teams, providing expert quality oversight for AAV gene therapy manufacturing, process improvement initiatives, and alignment with quality objectives.
Establish and maintain effective partnerships with internal stakeholders, including Process Development, Analytical Development, and Manufacturing, to ensure quality assurance goals are met and maintained.
Ensure accurate and up-to-date documentation of all quality assurance activities related to AAV gene therapy manufacturing, maintaining compliance with record-keeping requirements.
Monitor regulatory requirements, industry trends, and best practices related to AAV gene therapy manufacturing, and implement necessary changes to maintain compliance and drive continuous improvement initiatives.
What You’ll Bring
Bachelor’s Degree in a scientific or related field (or equivalent experience).
3-5 years of experience in a quality assurance role within the pharmaceutical or biotechnology industry.
In-depth knowledge of cGMP regulations, quality systems, and quality assurance principles.
Proven experience managing document control processes and systems, including SOPs, work instructions, and forms.
Extensive experience in reviewing and approving batch records for manufacturing, ensuring compliance with cGMP regulations.
Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation.
Experience leading internal audits, including planning, execution, and reporting, with a thorough understanding of audit principles and practices.
Proficiency in using quality management systems (e.g. Veeva) and document control software.
Proficiency in using electronic quality management systems and document control software.
Excellent communication and leadership skills, with the ability to guide and mentor junior team members and collaborate effectively with cross-functional team members.
Proficiency in using electronic quality management systems and document control software.
Ability to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.
Work Environment and Physical Demands
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, 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.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
HARDWORKING – We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
OPEN – We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
PURPOSE DRIVEN – We are passionate about working towards and delivering on our mission to manufacture gene therapies.
ENGAGED – We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals.
We’ve Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.
Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
Competitive PTO (plus 14 paid company holidays)
Annual bonus for all full-time employees
401(K) company match
Fully-stocked kitchen with free food/drinks
12 weeks of paid parental leave – additional discount programs include childcare support & dependent care
Employee Assistance Program
Onsite gym
Wellness benefits (financial planning services, mental health counseling, employer paid disability)
Professional & Personal development resources
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Title: Software Quality Assurance Engineer
Company: CS Group
Location: East Hartford, CT
