Associate II, Quality Systems

The Role:

ElevateBio is looking for a detail-oriented Quality Systems Specialist to join the Quality Systems & Compliance team. In this role, you will support effective document control processes and training program administration to maintain a strong and sustainable quality framework. You will also provide quality oversight of GxP computerized system validation activities to help ensure systems remain compliant and inspection-ready.

Here’s What You’ll Do:

Document Control & Training

• Support the lifecycle management of GMP-controlled documents in an electronic Document Management System (eDMS), including review, revision, and archiving activities.


• Help maintain document control processes in the Document Control room and within the eDMS to support compliance and audit readiness.


• Assist with Learning Management System (LMS) activities and help maintain accurate GxP training records.


• Support curriculum and training content updates as procedures and systems change, under team guidance.


• Work with team members and stakeholders to help resolve basic document and training-related questions.

Digital Quality

• Provide quality oversight of GxP computerized system validation activities


• Review validation deliverables (plans, risk assessments, test scripts, summary reports) for compliance and completeness


• Apply working knowledge of 21 CFR Part 11, EU Annex 11, and data integrity principles


• Support change control, deviation, and periodic review activities to maintain validated state


• Collaborate with IT and system owners on new system implementations and upgrades

General

• Execute responsibilities independently with limited supervision


• Identify and escalate compliance risks appropriately


• Contribute to continuous improvement of Quality Systems processes


• Support audit and inspection readiness activities

Requirements:

• Bachelor’s degree in Life Sciences, Engineering, Quality, Computer Science, or related technical field (or equivalent experience)


• 2–5 years of experience in a GMP/GxP-regulated environment within Quality Systems, Computerized System Validation, Document Control, or Training


• Experience supporting document control within a Quality Management System


• Experience reviewing or supporting computerized system validation documentation and data integrity assessments


• Working knowledge of data integrity expectations and electronic records requirements


• Familiarity with eQMS, LMS, or other GxP computerized systems (Veeva experience a plus)


• Ability to manage multiple priorities with limited supervision


• Strong attention to detail and effective written and verbal communication skills

Nice to Have

• Experience supporting audits or regulatory inspections


• Experience in a biotech or cell and gene therapy environment