Associate II, Quality Systems

ElevateBio • Pittsburgh, PA

8h

About The Position

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.

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 Haves

• Experience supporting audits or regulatory inspections
• Experience in a biotech or cell and gene therapy environment

Responsibilities

• 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.
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level