What are the responsibilities and job description for the Change Control Specialist position at Intellectt Inc?
Job Title: Change Control Specialist
Location: Rocky Mount, NC
Duration: 18 Months
We are seeking a skilled and experienced Change Control Specialist to take ownership of change control processes for critical projects. This role requires a solid understanding of change management in regulated environments, strong project coordination skills, and the ability to drive complex changes from initiation to completion.
Key Responsibilities:
1. Own and coordinate end-to-end change control processes for assigned projects, from initiation to closure
2. Prepare, document, and submit change requests using appropriate systems and forms
3. Conduct thorough impact assessments and risk analyses for proposed changes
4. Coordinate review and approval processes with stakeholders and decision-makers
5. Support the implementation of approved changes, including timeline tracking and resource coordination
6. Monitor and report on the progress and effectiveness of implemented changes
7. Take ownership of specific change control actions as outlined in project scope documents
8. Maintain detailed records of all change control activities, decisions, and outcomes
9. Ensure compliance with industry regulations and organizational policies throughout the change control process
10. Analyze the effectiveness of implemented changes and suggest opportunities for process
improvement
Qualifications:
1. Bachelor’s degree in Engineering, Life Sciences, or a related field
2. Minimum of 5 years of experience in change control within a regulated industry (e.g., pharmaceutical, medical device, biotechnology)
3. Expertise in using electronic quality management systems, preferably TrackWise
4. Strong understanding of GMP, FDA, and other relevant regulatory requirements
5. Solid project coordination skills with the ability to manage multiple changes simultaneously
6. Excellent analytical and problem-solving skills
7. Strong communication and interpersonal abilities to effectively collaborate with cross-functional teams
Required Skills:
1. Proficiency in change management methodologies and best practices
2. Knowledge of quality management systems and processes
3. Experience in risk assessment and mitigation strategies
4. Strong technical writing skills for preparing comprehensive change control documentation
5. Ability to work effectively with stakeholders at various levels of the organization
Preferred Qualifications:
1. Familiarity with Lean Six Sigma methodologies
2. Experience with validation processes for computerized systems in GxP environments
