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Cambrex High Point QC Data Review Scientist - ($2,500 Sign-on Bonus) (evenings 8:30pm-7:00am) in Charles City, Iowa

 

At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

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.

Responsibilities

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

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 is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Job LocationUS-IA-Charles City

Type Regular Full-Time

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