Scientist - Analytical Testing

About the Role

We are seeking a Change Management Specialist to support analytical operations within a regulated laboratory environment. This role is responsible for managing documentation, coordinating change control activities, and ensuring compliance with quality and regulatory requirements. The selected candidate will partner with cross-functional teams to drive change requests through completion while maintaining accurate documentation. This position is ideal for professionals with strong cGMP experience, excellent documentation skills, and the ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Create, initiate, manage, and track change control documentation for analytical operations.
• Coordinate change requests and ensure all activities are completed within established timelines.
• Review change proposals and work with requestors to prepare documentation for approval.
• Facilitate meetings with cross-functional teams to support change management activities.
• Monitor open change requests and provide regular status updates to stakeholders.
• Maintain accurate and compliant documentation in accordance with cGMP requirements.
• Prepare and update controlled documents including standard operating procedures and test methods.
• Support preparation of protocols and reports for method validation, method transfer, and instrument qualification activities.
• Ensure documentation complies with internal procedures and regulatory requirements.
• Serve as the departmental subject matter expert for the electronic change management process.

Qualifications

• Bachelor of Science degree in a scientific field.
• Minimum of 3 years of experience in a cGMP regulated environment.
• Strong documentation and technical writing skills.
• Knowledge of change management and change control processes.
• Excellent oral, written, and presentation skills.
• Strong computer proficiency using MS Office applications including Word, Excel, and PowerPoint.
• Ability to work effectively in a collaborative project team environment.

Preferred Qualifications

• Experience with analytical laboratory testing including chromatography and wet chemistry.
• Experience supporting method validation and method transfer activities.
• Experience with instrument qualification documentation.
• Knowledge of electronic change management systems.

Pay

$40 to $50 an hour.

Contract Duration

12 Months Contract (Possibility of Extension based on business needs and performance).

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time off (including sick and safe time, vacation time, and holidays)
• Weeks of paid parental leave

To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn) or email your updated resume at deepak.arya@collabera.com.