Job Information
Cambrex High Point Quality Control Chemist II - Raw Material in Charles City, Iowa
Company Information
You Matter to Cambrex.
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 more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
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!
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
Data review
Data entry
Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability
Maintain/support laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ
Perform in-depth laboratory investigations of non-complying test results.
Working knowledge of chromatography
Working knowledge of wet chemistry
Write controlled documents such as reports, test procedures, SOPs, etc.
Evaluate validity of test results
Independently troubleshoot equipment
Perform and document method transfer from Analytical Development
Run method evaluation experiments
Handle, analyze and dispose of hazardous samples and waste
Provide off-shift coverage as required
Maintain laboratory solutions, inventory and notebooks
Responsible for assisting in training employees as needed both inside and outside the department
Coordinate and communicate project status
Interacting with outside vendors and other departments
Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City.
Proven ability to handle various assignments and organize workload to meet timelines
Act as departmental subject matter expert (SME)
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.
Education, Experience & Licensing Requirements
BS/BA in Chemistry/Biology or related science field required
Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred
Three years laboratory cGMP environment (preferred NLT 5 years) with a BS or advanced degree
Strong cGMP experience
Experience testing against USP and EP compendia.
Working knowledge of analytical instrumentation (GC, HPLC minimum)
Working knowledge of NMR, DSC, IC, and/or ICP-OES preferred
Strong chemistry theory
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
Ability to work independently with little or no direct supervision
Mass Spectrometer experience 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.
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