Quality Control Data Review Scientist - Days

Job Overview

The Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure compliance with SOPs, compendial, and CGMP requirements.

Responsibilities

• Reviews raw technical data provided by technicians, chemists, and laboratory supervision to ensure accuracy, completeness, and correct scientific conclusions have been drawn.
• Identifies data inaccuracies, incomplete inferences, and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages.
• Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination.
• Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols.
• Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents.
• Works alternative schedules to support output and data review of laboratories based on business need.

Qualifications/Skills

• Strong chemistry knowledge with proven ability to handle various project loads is beneficial.
• Bachelor’s degree in chemistry with three years’ experience in a pharmaceutical and cGMP environment highly preferred.
• Experience in a laboratory environment highly preferred.
• Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc.) required.

Requirements

• Bachelor’s degree in chemistry.
• Three years’ experience in a pharmaceutical and cGMP environment.
• Experience in a laboratory environment.
• Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc.).

Benefits

Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the ‘Arthur I. Mendolia Scholarship Program.’ Relocation assistance will be offered for this position.

About the Role

Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve, learn new skills and enjoy new experiences in an engaging and safe environment, strengthen connections with coworkers and the community. We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.

Schedule

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly.