Quality Control Chemist

2 weeks ago

Charles City, Iowa, United States Cambrex High Point Full time

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

Were 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

Reporting to the QC Supervisor, the QC Chemist I is responsible for raw material, in-process, isolated intermediate, or finished good testing in a GMP laboratory environment.

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

Qualifications/Skills

+ Working knowledge of analytical instrumentation (GC, HPLC minimum)

+ 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 direct supervision

Education, Experience & Licensing Requirements

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

+ 2+ years laboratory cGMP environment with a BS or advanced degree

+ Strong cGMP experience

+ Experience testing against USP and EP compendia.

Ability to lift and move items up to 25 pounds.

Must be able to perform tasks requiring physical mobility, including standing for long periods, bending, and reaching.

Exposure to chemicals, moving parts, vibration, and noise within a laboratory setting.

May require occasional travel for training or method transfer activities.

Flexible to work different shifts if necessary to meet critical deadlines.

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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