Quality Control Analyst Jobs in Columbus, OH at Forge Biologics
Title: Quality Control Analyst
Company: Forge Biologics
Location: Columbus, OH
Job Title:Analyst, Quality Control
We are currently seeking a Quality Control (QC) Analyst to join the Forge Biologics team. This is an exciting opportunity to help lead the laboratory efforts and execute characterization testing and assays for Quality Control. The candidate will optimize existing and implement new technologies and systems into Quality Control for research and GMP purposes. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.
The QC Analyst provides Biochemistry and/or Molecular Biological expertise for the Forge GMP facility in Grove City, OH. This will include technical writing, routine testing, and all other associated activities. The QC Analyst responsibilities include, but are not limited to; training, sampling, routine testing, method qualification/validations, and investigations. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with Quality Management. The QC Analyst may also support the QC management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.
Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The QC Analyst may be responsible for performing the in-process and release testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories, as well as raw materials, to ensure they conform to manufacturer specifications. The QC Analyst will execute the procedures designed to demonstrate safety, efficacy, and purity of the drug products under evaluation. The QC Analyst may be responsible for upstream (cell culture and virus production) and downstream (harvest and purification) testing activities to support a singular “platform” process for the entire AAV program portfolio.
Conducts Biochemistry and Molecular Biological testing that incorporates application of GMP principles and methodologies.
Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
Drafts and revises process documents, assay methods, and sampling plans.
Trains junior staff in laboratory skills and scheduling lab/equipment maintenance.
Plans work to meet production and schedule requirements from clients (internal and external).
Prepares and presents data associated with manufacturing processes and transfer activities to clients.
May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
Reviews and trends QC data (molecular biology and/or biochemistry) and publishes trend reports on a routine basis.
Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay. May also represent QC as a SME during audits and inspections.
Delivers results in a high paced environment.
Supports packaging and shipping finished product and/or coordinates the effort.
Additional responsibilities not listed may be assigned as needed by management.
Minimum Bachelor’s Degree (B.A. or B.S.) in Molecular Biology, Biochemistry, Biotechnology, Microbiology, or equivalent industry experience.
Experience in a Quality Control laboratory or GMP laboratory is preferred but not required
Must be self-motivating, organized, and proactive.
Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
Ability to work flexible hours necessary to support production and/or product transfer activities.
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.
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.
Special Knowledge or Skills Preferred:
Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
Experience with an electronic Document Management System.
Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
Knowledge of biopharmaceutical manufacturing process workflows.
Knowledge in the following system(s): Cell Culture, Cell-based assays, Pharmaceutical Utilities, HPLC, LC/MS, Microbial testing and identification, Mass Spectrometry, AUC, qPCR and ddPCR, ELISA, gel electrophoresis.