Job Description

Job Description

Job Description

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

The Quality Assurance Associate/Specialist provides quality assurance and operational expertise for the Forge GMP facility in Grove City, OH. This will expertise and guidance in application of governmental regulations, agency guidelines and internal policies to assure compliance. The Quality Assurance Associate/Specialist responsibilities include, but are not limited to; controlled documentation issuance, batch record review, verification of manufacturing activities (including operations within aseptic areas), standard operating procedure creation and review, investigations, and implementing corrective and preventive actions.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The Quality Assurance Associate/Specialist must demonstrate accountability, transparency, and effective communication cross-functionally and within the QA team.

What You'll Do

• Serves as a quality resource for the GMP Manufacturing department during operations.
• Responsible for the issuance or review of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc.
• Review of executed batch documentation for compliance to procedures, regulations, and Good Documentation practice
• Proactively identify and implement items to enhance quality through continuous improvement (CAPA)
• Responsible for the authoring or review and approval of investigations, CAPAs and change controls to drive for resolution through root cause analysis.
• Supports internal and external audits as needed.
• Additional responsibilities not listed may be assigned as needed by management.

What You'll Bring

• Must be able to effectively communicate to management Quality issues that arise during the manufacturing of product or review of batch documentation.
• Ability to work independently and in a group
• Ability to maintain a high degree of accuracy and attention to detail. Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively.
• Ability to monitor and report on assigned tasks, goals, and objectives
• Plans work to meet production and schedule requirements from clients (internal and external).in a high paced environment.
• Thoroughly knowledge with pharmaceutical cGMP requirements, including strong working knowledge of FDA and EU requirements / guidance documents.
• Must be able to work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
• Intermediate level skill in Microsoft Word, Excel, PowerPoint, Outlook and other office software programs.

Preferred Skills

• Experience executing aseptic processes or working within biological safety cabinets or cleanroom environment
• Experience with root cause analysis and investigations, including technical writing skills.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Experience with an Electronic Document Management System (EDMS) and Enterprise Resource Planning (ERP) software.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Knowledge in the following system(s): Cell Culture and Cell-based assays, Pharmaceutical Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR, ELISA, and gel electrophoresis.
• Experience supporting inspections performed by FDA and foreign Regulatory Authorities.

Requirements:

• Minimum Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
• Experience in a GxP environment is required.
• Detailed/Demonstrated strong working knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements.
• Thorough knowledge and application of Good Documentation Practices (GDP).
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Strong interpersonal skills to work with a diverse team
• Ability to work hours necessary to support production and/or product transfer activities.
• Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile manufacturing suites.
• Ability to work in confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
• Ability to work independently with minimal supervision.
• Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.

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. 

H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

E NGAGED - 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 Un FORGE ttable.

• 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

• Flexible 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

• Wellness benefits (financial planning services, mental health counseling, employer paid disability)

• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches

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