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Job Description

Insight Global is seeking a Change Control Specialist to support a pharmaceutical manufacturer in the Sanford, NC area. This role is supporting engineering and is focused on electronic Quality Management Systems (eQMS) involves overseeing and implementing changes within an organization’s quality processes using digital platforms. The position ensures compliance, documentation, and process improvement through the eQMS.

Key Responsibilities:

Manage and execute change controls across engineering, project engineering, and core engineering teams

Populate and maintain change control records in Veeva Vault, including investigations and auto responses

Collaborate with cross-functional teams to ensure timely and compliant change control execution

Assist in onboarding new manufacturing and facility equipment (e.g., production lines, autoclaves)

Ensure compliance with GMP standards and pharmaceutical industry regulations

Participate in site expansion initiatives and support equipment integration projects

Manage and coordinate change control processes within the eQMS

Ensure all changes are documented, reviewed, and approved according to regulatory and company standards

Collaborate with cross-functional teams to assess the impact of proposed changes

Monitor the implementation of changes and verify effectiveness

Maintain accurate records and reports within the eQMS

Provide training and support to users on change management procedures in the eQMS

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

Proven experience with Veeva Vault (change controls, investigations, document control)

Background in GMP-regulated pharmaceutical environments

Experience supporting engineering teams in a fast-paced, growth-oriented setting

Familiarity with facility and manufacturing equipment change controls (lab equipment experience not required)

Prior roles such as Change Control Specialist, Investigator, or similar

Strong organizational and communication skills