Overview
Control Specialist Jobs in Rocky Mount, North Carolina, USA at Intellectt Inc
Position: Change Control Specialist
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:
Own and coordinate end-to-end change control processes for assigned projects, from initiation to closure
Prepare, document, and submit change requests using appropriate systems and forms
Conduct thorough impact assessments and risk analyses for proposed changes
Coordinate review and approval processes with stakeholders and decision-makers
Support the implementation of approved changes, including timeline tracking and resource coordination
Monitor and report on the progress and effectiveness of implemented changes
Take ownership of specific change control actions as outlined in project scope documents
Maintain detailed records of all change control activities, decisions, and outcomes
Ensure compliance with industry regulations and organizational policies throughout the change control process
Analyze the effectiveness of implemented changes and suggest opportunities for process improvement
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related field
Minimum of 5 years of experience in change control within a regulated industry (e.g., pharmaceutical, medical device, biotechnology)
Expertise in using electronic quality management systems, preferably Track Wise
Strong understanding of GMP, FDA, and other relevant regulatory requirements
Solid project coordination skills with the ability to manage multiple changes simultaneously
Excellent analytical and problem-solving skills
Strong communication and interpersonal abilities to effectively collaborate with cross-functional teams
Required Skills:
Proficiency in change management methodologies and best practices
Knowledge of quality management systems and processes
Experience in risk assessment and mitigation strategies
Strong technical writing skills for preparing comprehensive change control documentation
Ability to work effectively with stakeholders at various levels of the organization
Preferred Qualifications:
Familiarity with Lean Six Sigma methodologies
Experience with validation processes for computerized systems in GxP environments
Seniority Level:
Mid-Senior level
Employment Type:
Contract
Job Function:
Pharmaceutical Manufacturing
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Title: Control Specialist
Company: Intellectt Inc
Location: Rocky Mount, North Carolina, USA
Category: Quality Assurance – QA/QC, Business
