Specialist I, QA Operations

About The Role:

Responsibilities:

• Serves as a quality resource for the GMP AAV Manufacturing department directly overseeing operations in the cleanroom manufacturing environment, providing guidance and effectively communicat ing to management Quality issues that arise during the manufacturing of product.
• Perform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to established procedures and cGMP regulations.
• Provide training and guidance to manufacturing personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
• S upport deviations and continuous improvements related to AAV gene therapy manufacturing processes, assist with root cause analysis and identification of CAPA measures to prevent recurrence.
• Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives.
• Support the documentation control process for AAV gene therapy manufacturing, including reviewing and revising SOPs, work instructions, and forms to ensure compliance with regulatory requirements and industry best practices.
• Assist in the preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing.

Qualifications:

• Bachelor’s Degree in a scientific or related field (or equivalent experience).
• Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry.
• Proven track record of keen attention to detail, consistently ensuring accuracy and precision in all tasks and documentation, managing multiple priorities in a fast-paced environment
• Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust.
• Strong communication skills, including the ability to effectively communicate quality issues to senior management.
• Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues.
• Ability to work in a GMP cleanroom environment as needed to support manufacturing operations, which includes wearing required PPE such as gowns, gloves, masks, and safety glasses.
• Preferred Skills:
• Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment.
• Experience working in the production of biologics (ex. gene therapies).
• K nowledge of cGMP regulations, quality systems, and quality assurance principles.
• Experience utilizing an eQMS, preferably Veeva Vault or another document management system.
• Intermediate proficiency in Microsoft Office applications (Outlook, Teams, Word, Excel, and PowerPoint ).
• Experience supporting internal audits and participating in external audits or inspections.
• 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.
• Work Environment and Physical Demands
• This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.
• 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.