• QC Data Review

    Cambrex High Point (Charles City, IA)


    Company Information

     

    You Matter to Cambrex.

     

    Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

     

    With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

     

    Your Work Matters.

    At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

    + engage in work that matters to our customers and the patients they serve

    + learn new skills and enjoy new experiences in an engaging and safe environment

    + strengthen connections with coworkers and the community

     

    We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

     

    Your Future Matters.

     

    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. Start a career where You Matter by applying today!

     

    Job Overview

     

    The QC Data Review Scientist (Night Shift) 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

    Adhere to all EPA, FDA, cGMP, cGLP DEA regulations and internal SOP's as they relate to the operation of the Quality Control lab and general operation of the chemical production facility.

     

    • Follow all OSHA and company safety rules and practices.

    • 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.

    • Provide off-shift coverage as required

    • Maintain laboratory inventory and notebooks.

    • Responsible for assisting in training employees as needed

    • Coordinate and communicate project status

     

    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/Skills

    + Proven ability to handle various project load is preferred

    + Ability to work in a fast-paced, deadline driven work environment

    + Strong attention to detail

    + Effective communication skills (oral, written)

    + Ability to work well with others in a team environment

     

    Education, Experience & Licensing Requirements

     

    + BS/BA in Chemistry/Biology or related science field required

    + Experience in a laboratory environment or quality assurance preferred

     

    Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

     

    All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.