The Sr. Specialist / Specialist, QA Operations will be responsible for supporting Quality's oversight of laboratory and manufacturing operations at Beam's manufacturing facility in RTP, North Carolina. The NC manufacturing facility is a greenfield build and will build out in various phases over a 6-8 year period, with a focus on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility will start as a clinical phase manufacturing plant with the intent to move several programs to commercial within the same facility.
The role will support plant start-up and routine operations thereafter to ensure that systems and processes are maintained to ensure compliance to Good Manufacturing Practices, and ultimately to Good Distribution Practices as the programs move to the commercial phase. This role will provide Manufacturing Shop Floor Quality presence. This role will begin as first shift with a transition to 2nd shift by Quarter 2 2024.
The responsibilities of this role will cover aspects of the QA Operations team including, batch record review, logbook review, asset inductions and work order approvals, release of incoming raw materials and consumables, approval of associated deviations/CAPAs, and support of product disposition activities. The position will report into Beam NC, QA Operations Manager.
The Sr. Specialist / Specialist, QA Operations is expected to be on-site resource, with alternate shift schedule, for project start-up and routine clinical and commercial operations.
- Individual will partner with other functional areas for site start-up activities, quality risk management, ongoing continuous improvement and future scale-up as well as for problem resolution.
- Provide quality oversight of on the floor activities including manufacturing shop floor presence during operations.
- Responsible to ensure GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
- Responsible for assisting with product disposition activities of supply produced at the manufacturing facility.
- Real time review of batch records and labels.
- Review and approval of manufacturing discrepancies.
- Communicating lot disposition pending issues to management.
- Aid in the development and ongoing improvement of applicable quality systems for the site; identifying gaps or improvements, authoring and approval of procedures, and providing training.
- Review and approve calibration and maintenance work orders and asset inductions.
- Support approval of validation protocols when required.
- Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues.
- Responsible for supporting functional and facility goals and objectives.
- Responsible for supporting and contributing to quality metrics for the facility.
- Responsible to support and participate in regulatory inspections.
- Responsible for communicating escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image to senior management.
Embodies Beam's cultural values and aligns daily actions with departmental goals and company culture.
- Bachelors or Advanced degree in a scientific discipline with 8+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
- Knowledge of aseptic processing, and/or cell and gene therapy is preferred.
- Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
- Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
- Knowledge of global regulations and standards.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
- Excellent listening, communication and interpersonal skills fostering team spirit.
- Consistent delivery of high-quality work at all times.
- Ability to gown and work in a cleanroom environment.
- Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
- Ability to support 2nd shift schedule overtime.