Sr. Specialist I, Product Quality Assurance

Position Overview:

The Sr. Specialist I, NC Product Quality Assurance (PQA) 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 focused on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility is currently focused on clinical phase manufacturing with the intent of moving several programs to be commercial within the same facility.

The role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase. This role will also provide Manufacturing Shop Floor Quality presence and may require support on first or second shift as required by plant scheduling.

The responsibilities include batch record review, logbook review, asset inductions and work order approvals, approval and management of associated Deviations/CAPAs, and support of product disposition activities. The position will report into Beam NC, Director of PQA.

The Sr. Specialist I, NC PQA is expected to be an on-site resource, with alternate shift schedule, for project start-up and routine clinical and commercial operations.

Primary Responsibilities:

• Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations.
• Provide Quality oversight of QC testing.
• Responsible for ensuring 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 and associated CAPA’s.
• 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, as needed.
• Review and approve calibration and maintenance work orders and asset inductions.
• Support approval of protocols when required.
• Support tech transfers.
• Support commissioning, qualification, and validation of equipment.
• 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 for supporting and participating in regulatory inspections.
• Responsible for communication and escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or company impact to senior management.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline with 10+ 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.
• Apply 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 with a team focus.
• Consistent delivery of high-quality work.
• 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.