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QC Data Review Scientist

Location

Charles City, IA, USA

Department

Quality Control

To apply for this job please visit the following URL: Apply now →

  • GENEROUS RELOCATION ASSISTANCE!!
  • #1 small molecule API Contract Manufacturing Organization (CMO) in the USA
  • Double digit sales growth each of the last 5 years
  • Recent $75 million expansion of our large-scale API facility
  • IOWA – Ranked #1 state for best place to live by US News and World Report
  • Leading Western supplier of generic APIs including ADHD and other controlled substances

 

Position Summary:

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.

 

Accountabilities and Responsibilities:

  • Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records.
  • 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.

 

All employees are required to adhere to EPA, DEA, 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.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications:

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

 

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.

 

Link to Apply: https://careers-cambrex.icims.com/jobs/1936/qc-data-review-scientist/job?mode=view&mobile=false&width=751&height=500&bga=true&needsRedirect=false&jan1offset=-360&jun1offset=-300

 

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