Quality Control Analyst
We are currently seeking a Quality Control Analyst (Environmental Monitoring) to join the Forge Biologics team. The Environmental Monitoring Team works in concert with and assists the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. This is an exciting opportunity to contribute to and lead efforts in the execution of manufacturing life changing gene therapies for human use. The candidate will participate in EM sampling, testing and provide hands-on support for new technologies and systems in our GMP manufacturing facility. The ideal candidate will be skilled in EM technical problem-solving to support our growth in the Gene Therapy sector.
The QC Analyst provides manufacturing and operational 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, support manufacturing activities, EM trending, investigations and QC microbiology support. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with QC, QA and Operations 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 is responsible for performing the routine, special and EMPQ sampling. The QC Analyst will execute the procedures designed to assure safety, efficacy, and purity of the drug products being manufactured. The QC Analyst may be responsible for upstream (cell culture and virus production) and/or downstream (harvest and purification) EM support activities to support a processes for the entire AAV program portfolio.
Responsibilities:
- Performs EM sampling that incorporates application of GMP principles and methodologies.
- Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas.
- Support trending of EM data using software’s eg: JMP and LIMS.
- Supports thorough investigations to determine root cause of OOS investigations the implementation of appropriate corrective and preventative actions in a timely manner.
- Trains junior staff in laboratory skills and scheduling EM sampling.
- Plans work to meet production and schedule requirements from clients (internal and external).
- Prepares EM data forms, EM labels and execute the EM testing.
- Delivers results in a high paced environment.
- Participates in Media Fill/Process Sims qualifications.
- Additional responsibilities not listed may be assigned as needed by management.
Requirements:
- Minimum of a High School Diploma or GED equivalent required.
- Bachelor's Degree in microbiology, biology or related scientific field preferred. (or equivalent work experience).
- Minimum 1-2 years’ experience in a GMP or QC environment strongly preferred.
- Must be self-motivating, organized, and proactive.
- Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
- Ability to work hours necessary to support QC and production
- Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.
- Knowledge of aseptic technique preferred.
- 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 sterile gowning attire as needed.
- Ability to work independently with minimal supervision.
- Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
- 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.
- Knowledge of aseptic technique preferred and attention to detail required.
- Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas
- Working knowledge of MS-Office software and PC Skills Required.