Change Control Specialist (Quality Documentation)

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

Change Control Specialist (Quality Documentation): Onsite, Branchburg, NJ

Location: Branchburg, NJ (100% onsite)
Pay Rate: $28-$30/hour

The Fountain Group is hiring a Change Control Specialist for a prominent client in the biopharmaceutical industry. In this role you will own the full lifecycle of change controls and author the controlled documentation behind them, partnering with Quality, Manufacturing, Engineering, and other teams in a regulated environment.

What You'll Do

• Author and revise controlled documentation, including SOPs, work instructions, batch records, and forms (about 25% of your time)
• Act as initiator for change controls, managing each one from start to finish through implementation and closure, often with complex tasks and tight deadlines
• Serve as a subject matter expert in document creation, formatting, and EDMS use, gathering information from SMEs and turning complex processes into clear, appropriately detailed steps
• Process controlled documents in the electronic document management system in line with policies and procedures
• Review and evaluate change requests of varying complexity with minimal supervision, and follow up on activities required for closure
• Collaborate with Manufacturing, Engineering, Process Development, Quality, Change Control, and CAPA/Quality Investigations teams to make sure documents reflect correct process and product specifications
• Guide change initiators through the process and provide training as needed
• Support process improvements for electronic document management
• Represent Quality Documentation and Change Control during regulatory audits
• Communicate regularly with management and escalated issues as needed
• Support 5S practices and help maintain a safe, pleasant work area

Must-Haves

• Strong hands-on change control experience: ideally 5+ years, though 3-4 years will be considered with the right background
• You have personally written, initiated, and managed change controls from start to finish, including implementation and closure. This is not a review-and-route role.
• Strong QA/Quality Systems background in a regulated pharmaceutical, biotech, or medical device environment
• Experience authoring and revising controlled documents such as SOPs, work instructions, and batch records
• Experience working cross-functionally with QA, Manufacturing, Engineering, and other stakeholders
• Working knowledge of FDA, GxP, 21 CFR 820, and ISO 13485 requirements
• Advanced MS Word skills (tables, headers/footers, review tools), strong proofreading and editing ability, and excellent written and verbal communication
• Ability to multi-task and adjust to shifting priorities

Highly Preferred

• Medical device manufacturing experience, especially with ISO 13485 and 21 CFR 820
• TrackWise experience, ideally managing changes from initiation through closure
• Experience with CAPA, deviations, investigations, and audit support
• Experience with tissue-based products, biologics, or regenerative medicine
• Experience with EDMS (Veeva Vault) and SAP
• Project management skills

Education

Bachelor's degree or 5-7 years of equivalent experience. Candidates with advanced degrees are welcome.

Additional Details

• This position is 100% onsite in Branchburg, NJ.
• Candidates relocating to the area are welcome to apply if they can start within 2-3 weeks.

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