Change Control Specialist

📋 Description

• Responsible for executing Good Manufacturing Practices (GMP) change control processes for various
• Have ownership of all analytical change activities of several change control requests
• Ensure the change control process is in accordance to associated specifications, procedures
• 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

🎯 Requirements

• Bachelor's degree in Life Sciences, Biology, Chemistry, Microbiology, or related scientific
• Minimum 5 years of pharmaceutical, biologics, laboratory operations, quality systems, or related
• 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.

🎁 Benefits

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays