Senior Technical Reviewer, GMP Analytics

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

Benefits offered by this job

Medical insurance

Dental and vision coverage

401(k) retirement plan with employer/2

Life and disability insurance

Job summary

Cambrex Corp. is seeking a Technical Reviewer to provide independent technical reviews for analytical data across small and large molecule development in compliance with cGMP/cGLP and FDA/EU regulations.

The role requires coordinating with cross-functional teams to ensure timely document reviews, laboratory investigations, and adherence to quality systems. Candidates should have a life sciences background and CDMO/pharma experience.

Qualifications

• BA/BS in Life sciences required.
• 4+ years of relevant experience in a CDMO and/or pharmaceutical environment.
• Experience in laboratory testing, preferably in the pharmaceutical or biotechnology industries.

Responsibilities

• Perform an independent technical review of analytical data for GMP compliance.
• Apply QA principles to ensure data is scientifically sound and regulatory compliant.
• Review protocols and technical reports for qualification/validation and stability activities.

Skills

Attention to detail

FDA/GMP knowledge

LIMS/Empower

MasterControl/Trackwise

Analytical techniques

Technical writing

Communication

Education

BA/BS in Life sciences

Tools

LIMS

Empower

MasterControl

Trackwise

MS Office

Job description

Cambrex Corp. is seeking a Technical Reviewer to provide independent technical reviews for analytical data across small and large molecule development in compliance with cGMP/cGLP and FDA/EU regulations.

The role requires coordinating with cross-functional teams to ensure timely document reviews, laboratory investigations, and adherence to quality systems. Candidates should have a life sciences background and CDMO/pharma experience.