Quality Assurance Associate, GxP Audits & Inspection Excellence

Alnylam; Cambridge (MA); Hybride; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Strong organizational skills

Attention to detail

GxP knowledge

Cross-functional collaboration

Documentation practices

Regulatory inspections support

Data integrity

Formation

Bachelor's degree in Life Sciences or related field

Outils

QMS software

TrackWise

Description du poste

Overview

The QA Associate, GxP Audits & Inspection Excellence, supports day-to-day operations of Alnylam's audit and inspection management program. This role is responsible for maintaining accurate records, trackers, and systems that enable inspection readiness, audit transparency, and efficient quality oversight. The role uses judgment within established processes to address routine matters and identify issues requiring additional review or escalation.

Reporting to the Associate Director, GxP Audits & Inspection Excellence, this position provides operational and administrative support for supplier quality management, audit lifecycle, and inspection readiness activities. The QA Associate plays a critical role in ensuring process compliance and data integrity within these operations.

This is a hybrid position primarily based in Cambridge, MA.

#LI-LJ1 #LI-Hybrid

Key Responsibilities

• 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.

Qualifications

• Bachelor's degree in Life Sciences or related field (or equivalent QA experience).


• 1-3 years of experience in a regulated pharmaceutical, biotechnology, 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.

About Alnylam

We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings.