Quality Control Chemist - Days

Cambrex Corp.; Charles City (IA); On-site; USD 48,000 - 75,000; Full time

Benefits offered by this job

Competitive benefits

Healthcare

Life insurance

Retirement planning

Job summary

Cambrex Charles City in Iowa seeks a Chemist I in Quality Control to perform chemical analyses ensuring release of materials and products. The role emphasizes compliance with EPA, FDA, cGMP, cGLP, and DEA regulations.

You will contribute to lab programs, calibration, preventive maintenance, method development, and troubleshooting of analytical instruments, while handling hazardous materials and providing data reviews.

Qualifications

• BS/BA in Chemistry/Biology or related science required.
• Three years laboratory cGMP environment (preferred NLT 5 years) with a BS or advanced degree.
• Experience testing against USP/EP compendia and working knowledge of GC/HPLC instrumentation.

Responsibilities

• Adhere to EPA, FDA, cGMP, cGLP, DEA regulations and internal SOPs in QC lab.
• Perform chemical analyses for release of raw materials, in-process materials, intermediates, finished goods, and stability.
• Maintain calibration and preventive maintenance programs for laboratory instruments.
• Troubleshoot analytical instruments and transfer methods from Analytical Development.
• Write controlled documents such as reports and SOPs; evaluate test results for validity.
• Provide off-shift coverage and collaborate with other departments as needed.

Skills

cGMP experience

Analytical instrumentation (GC, HPLC)

NMR/DSC/IC/ICP-OES knowledge

Chemistry theory

Attention to detail

Communication skills

Teamwork

Independent work

Mass spectrometry experience

Education

BS/BA in Chemistry/Biology or related science

MS/PhD in Chemistry/Biology or related science (preferred)

Tools

GC

HPLC

NMR

DSC

IC

ICP-OES

Job description

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.

Job Overview

The Chemist I in Quality Control is responsible for performing a variety of chemical analyses to ensure the release of raw materials, intermediates, and finished products. The role requires adherence to EPA, FDA, cGMP, cGLP, and DEA regulations, as well as company SOPs. The Chemist I also contributes to the development and maintenance of laboratory programs, such as stability testing, calibration, and preventive maintenance, and participates in method development and troubleshooting for analytical instruments. The position involves handling hazardous materials, conducting statistical evaluations of data, and providing on-call support as needed.

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.

Qualifications/Skills

• 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

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

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 / Affimative 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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