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QC Data Review Specialist

  • Permanent
  • Anywhere

Website Cambrex

Cambrex

Company : Cambrex

Country: United States

Location : Charles City, Iowa

Post: Sat, 30 Jul 2022 21:11:53 GMT

Expires: Sat, 27 Aug 2022 23:59:59 GMT

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—————————— Job Description ——————————

 :
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Overview:
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:
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 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. 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 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.

 

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. 

 

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