Change Control Lead - Quality Documentation Expert

The Fountain Group; Branchburg Township (NJ); On-site; USD 58,000 - 62,000; Full time

Job summary

The Fountain Group is hiring a Change Control Specialist for a prominent biopharma client. You will own the full lifecycle of change controls and author the controlled documentation behind them, partnering with Quality, Manufacturing, and Engineering in a regulated environment.

You will author SOPs, work instructions, and batch records, serve as EDMS SME, and guide change initiators to closure while supporting audits and process improvements. 100% onsite in Branchburg, NJ.

Qualifications

• 5+ years in change control; 3-4 years with strong background considered.
• Authoring and managing change controls from initiation to closure.
• QA/Quality Systems background in regulated pharma/biotech/medical devices.
• Experience authoring SOPs, work instructions, batch records.
• Cross-functional collaboration with QA, Manufacturing, Engineering.
• Strong knowledge of FDA, GxP, 21 CFR 820, ISO 13485.
• Advanced MS Word skills and excellent written/verbal communication.
• Ability to multi-task and adapt to shifting priorities.

Responsibilities

• Author and revise controlled documentation (SOPs, WIs, batch records).
• Act as change control initiator from start to finish through closure.
• Serve as SME in document creation, formatting, EDMS use.
• Process documents in the EDMS per policies and procedures.
• Review change requests of varying complexity with minimal supervision.
• Collaborate with Manufacturing, Engineering, Process Development, QA.
• Guide initiators through the process and provide training as needed.
• Support EDMS improvements and audit readiness.
• Represent Quality Documentation during regulatory audits.
• Communicate updates to management and escalate issues.

Skills

Hands-on change control

Quality Systems

Document authoring

Cross-functional collaboration

FDA/GxP knowledge

MS Word advanced

Multi-tasking

Education

Bachelor's degree / equivalent

Tools

Veeva Vault EDMS

SAP

TrackWise

Job description

The Fountain Group is hiring a Change Control Specialist for a prominent biopharma client. You will own the full lifecycle of change controls and author the controlled documentation behind them, partnering with Quality, Manufacturing, and Engineering in a regulated environment.

You will author SOPs, work instructions, and batch records, serve as EDMS SME, and guide change initiators to closure while supporting audits and process improvements. 100% onsite in Branchburg, NJ.