Change Control Specialist

Change Control Specialist

We are seeking a detail-oriented and proactive Change Control Specialist to support the Engineering Compliance Group at our client's bio-pharmaceutical manufacturing facility. This role is critical to ensuring that all engineering-related changes are properly documented, assessed, and implemented in compliance with regulatory requirements, internal quality standards, and Good Manufacturing Practices (GMP). Key Responsibilities : Coordinate and manage the change control process for engineering projects, equipment modifications, and facility upgrades. Review and assess change control requests for completeness, accuracy, and regulatory impact. Collaborate with cross-functional teams (Engineering, Quality Assurance, Validation, Manufacturing) to ensure timely and compliant execution of changes. Maintain accurate records of change control documentation in electronic systems (e.g., TrackWise, Veeva, or equivalent). Ensure changes are evaluated for impact on validated systems, regulatory filings, and GMP compliance. Support internal and external audits by providing documentation and responding to inquiries related to change controls. Monitor and report on change control metrics and KPIs to identify trends and opportunities for process improvement. Assist in training engineering and technical staff on change control procedures and compliance expectations.

Skills : change control, GMP, engineering, Compliance, veeva vault, Document control

Additional Skills & Qualifications : Familiarity with validation protocols and regulatory submission processes. Experience supporting capital projects or facility expansions. Knowledge of risk assessment methodologies and impact analysis.

Experience Level : Intermediate Level

Pay and Benefits : The pay range for this position is $30.00 - $50.00 / hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off / Leave (PTO, Vacation or Sick Leave)

Workplace Type : This is a fully onsite position in Raleigh,NC.

Application Deadline : This position is anticipated to close on Sep 30, 2025.