Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.
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.
- 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.
- 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.
- 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.
- 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.
- In our commitment to safety of our employees and customers a COVID vaccination is required.