Change Control Specialist (Quality Documentation)

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 deadlinesServe as a subject matter expert in document creation, formatting, and EDMS use, gathering information from SMEs and turning complex processes into clear, appropriately detailed stepsProcess controlled documents in the electronic document management system in line with policies and proceduresReview and evaluate change requests of varying complexity with minimal supervision, and follow up on activities required for closureCollaborate with Manufacturing, Engineering, Process Development, Quality, Change Control, and CAPA/Quality Investigations teams to make sure documents reflect correct process and product specificationsGuide change initiators through the process and provide training as neededSupport process improvements for electronic document managementRepresent Quality Documentation and Change Control during regulatory auditsCommunicate regularly with management and escalate issues as neededSupport 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 backgroundYou 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 environmentExperience authoring and revising controlled documents such as SOPs, work instructions, and batch recordsExperience working cross-functionally with QA, Manufacturing, Engineering, and other stakeholdersWorking knowledge of FDA, GxP, 21 CFR 820, and ISO 13485 requirementsAdvanced MS Word skills (tables, headers/footers, review tools), strong proofreading and editing ability, and excellent written and verbal communicationAbility to multi-task and adjust to shifting priorities Highly Preferred Medical device manufacturing experience, especially with ISO 13485 and 21 CFR 820TrackWise experience, ideally managing changes from initiation through closureExperience with CAPA, deviations, investigations, and audit supportExperience with tissue-based products, biologics, or regenerative medicineExperience with EDMS (Veeva Vault) and SAPProject 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. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy