Change Control Specialist
About The Position
Responsible for executing Good Manufacturing Practices (GMP) change control processes for various laboratory testing. Have ownership of all analytical change activities of several change control requests, cross-functional proactive communication from start to finish, coordination to ensure key milestone completions, Second Person Review (SPR) as the change control Subject Matter Expert (SME) of the project. Ensure the change control process is in accordance to associated specifications, procedures, Standard Operating Procedures (SOPs), and regulations. Provide scientific and technical leadership for complex change control initiatives. Evaluate regulatory, compliance, operational, and technical impacts of proposed laboratory changes. Leads cross-functional teams through change planning, implementation, execution, and effectiveness verification. Develop and implement strategic improvements to change management processes. Review and approve complex change records, technical assessments, and supporting documentation. Lead root cause investigations and resolution of complex quality and compliance issues. Interpret regulatory expectations and develops solutions to maintain inspection readiness. Author and review technical reports, procedures, change strategies, and regulatory support documentation. Provide mentoring and technical consultation to laboratory and quality personnel.
Requirements
- Bachelor’s degree in Life Sciences, Biology, Chemistry, Microbiology, or related scientific discipline.
- Minimum 5 years of pharmaceutical, biologics, laboratory operations, quality systems, or related GMP experience.
- Extensive GMP laboratory, quality systems, or pharmaceutical industry experience.
- Proven expertise in change control, investigations, quality systems, and regulatory compliance.
- Experience leading complex technical initiatives across multiple departments.
- Demonstrated ability to evaluate and implement new technologies and methodologies.
- Strong analytical, problem-solving, organizational, and leadership skills.
- Excellent technical writing and stakeholder communication abilities.
- Authorization to work in the United States indefinitely without restrictions or sponsorship.
Responsibilities
- Executing Good Manufacturing Practices (GMP) change control processes for various laboratory testing.
- Ownership of all analytical change activities of several change control requests.
- Cross-functional proactive communication from start to finish.
- Coordination to ensure key milestone completions.
- Second Person Review (SPR) as the change control Subject Matter Expert (SME) of the project.
- Ensuring the change control process is in accordance with associated specifications, procedures, Standard Operating Procedures (SOPs), and regulations.
- Providing scientific and technical leadership for complex change control initiatives.
- Evaluating regulatory, compliance, operational, and technical impacts of proposed laboratory changes.
- Leading cross-functional teams through change planning, implementation, execution, and effectiveness verification.
- Developing and implementing strategic improvements to change management processes.
- Reviewing and approving complex change records, technical assessments, and supporting documentation.
- Leading root cause investigations and resolution of complex quality and compliance issues.
- Interpreting regulatory expectations and developing solutions to maintain inspection readiness.
- Authoring and reviewing technical reports, procedures, change strategies, and regulatory support documentation.
- Providing mentoring and technical consultation to laboratory and quality personnel.
Benefits
- comprehensive medical coverage
- dental options
- vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation
- Paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
