GxP Audit & Inspection Excellence QA Associate

Alnylam Pharmaceuticals, Inc.; Cambridge (MA); Híbrido; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Alnylam Pharmaceuticals, Inc. is seeking a QA Associate, GxP Audits & Inspection Excellence, to support the audit program, maintain accurate records, and enable inspection readiness across supplier quality management and audit lifecycles.

This hybrid role is based in Cambridge, MA. The candidate will assist in documentation, dashboard preparation, and regulatory inspection support while ensuring SOP compliance and data integrity within QMS systems.

Formación

• Bachelor's degree in Life Sciences or related field.
• 1-3 years of experience in a regulated pharmaceutical, biotech, or medical device environment.
• Strong organizational and time management skills.
• Demonstrated accountability and reliability in completing assigned responsibilities.
• Strong attention to detail and documentation practices.
• Working knowledge of GxP regulations and Quality Systems.
• Experience working in QMS or quality databases is preferred.
• Ability to work collaboratively in a cross-functional environment.
• Willingness to learn and develop within the Quality function.

Responsabilidades

• Support the execution of GxP audit and inspection processes in alignment with enterprise processes.
• Support audit and inspection lifecycle activities, including resourcing, coordination, facilitation of preparation and debrief meetings, documentation organization, tracker updates, and status reporting.
• Support preparation of audit and inspection materials, dashboards, and readiness documentation.
• Participate in regulatory inspections by performing assigned support roles, including document QC, scribing, and other activities, as applicable.
• Maintain and review audit and inspection records to ensure histories, timelines, commitments, and related information are complete, accurate, consistent, and compliant with SOPs.
• Support tracking of inspection commitments and CAPAs in collaboration with cross-functional colleagues.
• Support user access, data entry, and routine administration of audit and inspection systems.
• Provide administrative and operational support for other QMS activities, including deviations, CAPAs, change controls, and related quality records.
• Support process improvement activities, including development and updating of audit and inspection templates and tools.
• Use established procedures, available information, and sound judgment to make routine decisions within assigned responsibilities and determine when matters should be escalated.

Conocimientos

Strong organizational skills

Attention to detail

GxP knowledge

Cross-functional collaboration

Documentation practices

Regulatory inspections support

Data integrity

Educación

Bachelor's degree in Life Sciences or related field

Herramientas

QMS software

TrackWise

Descripción del empleo

Alnylam Pharmaceuticals, Inc. is seeking a QA Associate, GxP Audits & Inspection Excellence, to support the audit program, maintain accurate records, and enable inspection readiness across supplier quality management and audit lifecycles.

This hybrid role is based in Cambridge, MA. The candidate will assist in documentation, dashboard preparation, and regulatory inspection support while ensuring SOP compliance and data integrity within QMS systems.