Change Control Specialist Position Available In Mecklenburg, North Carolina

Change Control Specialist Imperium Life Sciences Charlotte, NC Job Details Full-time $70,000 – $92,000 a year 16 hours ago Benefits Health insurance Dental insurance 401(k) 401(k) matching Life insurance Qualifications Mid-level 3 years Project management Bachelor’s degree

ISO 13485 FDA

regulations Full Job Description Change Control Specialist $70,000 – $92,000 Monday to Friday 9am-5pm Pharmaceutical manufacturing Start date: ASAP I’m working with a Pharmaceutical Manufacturing company who are on the lookout for an Change Control Specialist technician to join their team in Charlotte North Carolina. This is a medium sized pharmaceutical company, but they are investing heavily in their staff and their infrastructure to be able to grow into a well-known household brand. This company already has a global presence and works with a wide array of clients themselves. These vary from small startups to some of the biggest names in the world, and you could be a part of this growing company. If you want to become a part of a team that invests in it’s staff to improve the overall company, that has clear paths of progression to promotions and a company that has committed to an impressive amount of growth in the next 5 years then this could be the company for you.

Responsibilities:

Change Control Management:

• Take the lead in managing the change control process—from starting a change request, evaluating and approving it, to making sure everything’s properly documented (like updates to product specs, manufacturing methods, or key documents).
• Run the Change Control Board (CCB) meetings, making sure all risks, impacts, and action plans are thoroughly reviewed before any decisions are made.
• Work closely with teams across the business—like Quality, Regulatory, Manufacturing, and R D—to make sure changes are clearly documented, traceable, and meet compliance standards.

Product and Process Changes:

• Review proposed changes to products or processes to ensure they meet regulations like ISO 13485 and FDA QSR (21 CFR Part 820).
• Help guide risk assessments and root cause analysis for changes, ensuring proper controls are in place to protect product quality.
• Partner with operations teams to roll out changes smoothly and check afterward that everything is working as expected.

Document Control & e

QMS Oversight:

• Oversee document control within the electronic Quality Management System (eQMS), making sure all documents are up-to-date, easy to find, and in line with both internal policies and regulatory standards.
• Manage document versions and workflows—like updates to SOPs, technical files, and product specs.
• Handle eQMS user access, permissions, and training, so everyone can securely and confidently manage their documents.
• Coordinate with relevant departments to verify and roll out documents from our Centers.
• Make sure all documents and records are stored properly and meet company and regulatory requirements.

Training & Support:

• Train and support teams on how to follow change control processes, perform risk assessments, and stay compliant.
• Run regular training sessions or refreshers to keep everyone up to date on best practices and any new eQMS features.

Requirements :

• A bachelor’s degree in Life Sciences, Engineering, or something similar.
• Over 3 years of hands-on experience working with change control in regulated industries—ideally in medical devices or pharma.
• Solid understanding of

FDA QSR, ISO

13485, and cGMP standards.

• Comfortable using electronic Quality Management Systems (eQMS) and handling document control.
• Great at communicating and staying organized, with strong project management skills—able to juggle multiple tasks in a fast-moving environment

Job Type:

Full-time Pay:

$70,000.00 – $92,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance

Schedule:

8 hour shift

Work Location:

In person