Quality Co-op

Beam TherapeuticsDurham, North CarolinaHybridCo-opListed 1 week ago

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About this role

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview :

Beam is seeking a highly energetic, talented, and motivated Quality Co-op to join our Quality team from January through June 2027. This role offers a unique opportunity to gain broad exposure to Quality Systems through rotations in both Document Control and Supplier Management. The co-op will work closely with cross-functional teams while supporting key quality processes and initiatives, providing a holistic view of how Quality functions support Beam's mission and operations.

Responsibilities:

Document Control/Training

- Quality Assurance Co-op for external collaborations will help provide quality system expertise and help identify solutions and ensure compliance to GMP.

- Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.

- Support the draft and review of Standard Operating Procedures (SOPs) and related GMP documents.

- Participate in system improvement initiatives to optimize the business processes and practices within Veeva.

- Participate in projects to support Quality Systems department holistically.

- Assess document metadata within Veeva for missing data and facilitate clean-up.

- Assist in organization of the Document Archival Room and enter paper archives into a database for tracking.

- Assist in logbook cleanup around site.

- Create Person Records and assign initial learner roles.

- Run the Veeva/Success Factors report and make any needed changes.

- Create Micro-learning trainings for wide personnel use.

- Create flow charts for all process areas.

- Document metadata updates (based on the +12K documents unassigned for product/stage/impacted departments).

- Assess GR records to solidify retention of all document types within the archived lifecycle.

- Curriculum Periodic Review.

- Assist with Learner Role/Curriculum Consolidation.

Supplier Management:

- Support BEAM-101 and BEAM-302 supplier commercialization activities.

- Assess authorized vendor qualification status.

- Complete Veeva supplier qualification documentation.

- Support reassessment of approximately 282 existing forms/records.

- Identify gaps and create replacement/new assessments as required .

- Align supplier risk assessments and vendor classifications.

- Document commercial-readiness status.

- Support SCN intake, assessment, tracking, and follow-up.

- Support associated Change Controls.

- Maintain visibility of aging and overdue actions.

- Track supplier audit responses and CAPAs.

- Follow up on overdue commitments.

- Review supporting evidence.

- Maintain audit records and closure documentation.

Qualifications:

- Pursuing a BA in Biotechnology, Bioengineering, Biochemistry, or related field.

- Prior industry internship or academic lab-based research experience is preferred.

- The candidate should have a solid academic foundation in science and laboratory coursework (examples: biology/chemistry/biochemistry, biochemical/bioengineering, microbiology, tissue culture, molecular biology, etc.)

- A team player who is curious, motivated to learn, organized, and possesses strong communication skills.

- This role follows a hybrid work schedule and requires onsite attendance 4-5 days per week.

- Applicants must be currently enrolled in a degree-granting college or university program and maintain their student status throughout the duration of the co-op to be eligible.

Hourly pay will will be determined based on several factors, including but not limited to, relevant experience, skills, and education.
Co-op Hourly Pay Range $23 — $30 USD