Quality Control Data Review Scientist - Nights
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.
Qualifications/Skills
- Education, Experience & Licensing Requirements:
- 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.
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
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.
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.