Quality Systems Specialist

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 Systems Specialist provides quality systems and operational expertise for the Forge GMP facility in Grove City, OH.

The Quality Systems Specialist will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations.

The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.

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

What You'll Do

• Serve as a quality resource for quality system principles, including documentation control, change control, deviations, CAPAs, and investigations.
• Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
• Make fact-based, scientifically and / or statistically sound, quality / regulatory compliant decisions that have impact on product release.
• Author or review and approve investigations, CAPAs and change controls to drive for resolution through root cause analysis.
• Author or review and approve controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, and Forms.
• Work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
• Support internal and external audits as needed.

What You'll Bring

• Bachelor's Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)
• Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation.
• Thorough knowledge and application of Good Documentation Practices (GDP).
• Experience in a GxP environment.
• Must be self-motivated, organized, and proactive.
• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements / guidance documents.
• 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.

Preferred Skills

• Experience with root cause analysis and investigations, including technical writing skills.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Experience supporting inspections performed by FDA and foreign Regulatory Authorities.
• Experience within a pharmaceutical, biotech, or related industry.
• Sterile injectable pharmaceuticals or biologics experience is preferred.
• Experience with Veeva Vault QMS.

Job Environment & Physical Demands

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job.

This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment.

Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically.

Must be able to move and / or carry objects weighing up to 10 lbs.

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
30+ days ago