QC Data Review Scientist- Nights

Cambrex • Charles City, IA

99d

About The Position

The Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure that they are compliant with SOPs, and compendial and CGMP requirements. This individual must have knowledge of instrument theory in order to thoroughly vet and review data and draw conclusions based on collected data.

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.

Nice To Haves

• Strong chemistry knowledge with proven ability to handle various project loads is beneficial.

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.
• Adheres 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.

Benefits

• Medical, dental, vision care and prescription
• Life insurance
• Long-term disability (LTD)
• Short-term disability (STD)
• 401(k) with employer match
• Tuition reimbursement
• Arthur I. Mendolia Scholarship Program
• Relocation assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees