Beam Therapeutics · 2 days ago
Specialist, Product Quality Assurance
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $145K/yr
10+ years expBeam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The Specialist, 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, ensuring compliance with Good Manufacturing Practices (GMP) and supporting product disposition activities.
BiotechnologyGeneticsMedicalTherapeutics
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
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
Embody Beam's cultural values and aligns daily actions with departmental goals and company culture
Qualification
Required
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
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
Preferred
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2026-01-23
2026-01-13
Company data provided by crunchbase