GxP Analytical Review Specialist

Cambrex; Longmont (CO); On-site; USD 86,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Life insurance

Wellness program

Job summary

Knowledge of LIMS/Empower and QMS tools, plus strong writing and communication skills, are essential. Colorado-based on-site position with a comprehensive benefits package.

Qualifications

• BA/BS in Life sciences required.
• 4+ years of relevant experience in a CDMO/pharma environment.
• Experience in laboratory testing in pharmaceutical/biotech industries.

Responsibilities

• Perform independent technical reviews of analytical data and documentation for GMP/GLP compliance.
• Review protocols and technical reports for qualification/validation and stability.
• Coordinate with analysts and lab management to document investigations.
• Deliver accurate data review and escalate issues impacting timelines.
• Ensure documentation is complete prior to approval.
• Support cross-functional teams to improve processes and quality.

Skills

Attention to detail

Integrity & work ethic

Clear written & oral communication

LIMS & Empower knowledge

QMS familiarity (MasterControl/Trackwi

Analytical techniques knowledge

Education

BA/BS in Life sciences

Tools

LIMS

Empower

MasterControl

TrackWise

Job description

Knowledge of LIMS/Empower and QMS tools, plus strong writing and communication skills, are essential. Colorado-based on-site position with a comprehensive benefits package.