Qureos Mentor

Cambrex

<div>Company Information<div></div><div><p><b><br>
You Matter to Cambrex.
</b></p></div><p>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.</p><div>
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.</div><div></div><div><p><b><br>
Your Work Matters.</b></p></div><p>
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:</p><ul><li>
engage in work that matters to our customers and the patients they serve
</li><li>learn new skills and enjoy new experiences in an engaging and safe environment</li><li>
strengthen connections with coworkers and the community</li></ul><p>
We&rsquo;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!</p><div><p><b>
Your Future Matters.</b></p></div><p>
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!</p><br>
<br>
Job Overview<div><br>
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.</div><br>
<br>
Responsibilities<br>
<ul><li>
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</li><li>
Follow all OSHA and company safety rules and practices</li><li>
Data review</li><li>
Data entry</li><li>
Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability</li><li>
Maintain/support laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ
</li><li>Perform in-depth laboratory investigations of non-complying test results.</li><li>
Working knowledge of chromatography</li><li>
Working knowledge of wet chemistry</li><li>
Write controlled documents such as reports, test procedures, SOPs, etc.</li><li>
Evaluate validity of test results</li><li>
Independently troubleshoot equipment</li><li>
Perform and document method transfer from Analytical Development</li><li>
Run method evaluation experiments</li><li>
Handle, analyze and dispose of hazardous samples and waste</li><li>
Provide off-shift coverage as required</li><li>
Maintain laboratory solutions, inventory and notebooks</li><li>
Responsible for assisting in training employees as needed both inside and outside the department</li><li>
Coordinate and communicate project status</li><li>
Interacting with outside vendors and other departments</li><li>
Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City.
</li><li>Proven ability to handle various assignments and organize workload to meet timelines
</li><li>Act as departmental subject matter expert (SME)</li><li>
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.</li></ul>
<br>
Qualifications/Skills<br>
<ul><li>
Strong cGMP experience</li><li>
Experience testing against USP and EP compendia.
</li><li>Working knowledge of analytical instrumentation (GC, HPLC minimum)</li><li>
Working knowledge of NMR, DSC, IC, and/or ICP-OES preferred</li><li>
Strong chemistry theory</li><li>
Proven ability to handle various project load is preferred</li><li>
Ability to work in a fast-paced, deadline driven work environment</li><li>
Strong attention to detail</li><li>
Effective communication skills (oral, written)</li><li>
Ability to work well with others in a team environment</li><li>
Ability to work independently with little or no direct supervision</li><li>
Mass Spectrometer experience preferred</li></ul>
<br>
Education, Experience &amp; Licensing Requirements<br>
<ul><li>
BS/BA in Chemistry/Biology or related science field required</li><li>
Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred</li><li>
Three years laboratory cGMP environment (preferred NLT 5 years) with a BS or advanced degree</li></ul><br>
<div></div>
<div><i>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.</i></div><div></div><div><i><br>
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.</i></div><div></div><div><i><br>
#LI-RD1</i></div></div><div></div>

Chemist I, Quality Control

<div>Overview:
<p>
The LIMS Business Analyst / Administrator is responsible for configuring, maintaining, and supporting the LIMS system to enable laboratory operations. This role builds and maintains Master Data, provides training and day‑to‑day user support, and collaborates with cross‑functional teams to implement improvements. The individual will serve as the site liaison to the technical LIMS team and translate laboratory workflows into LIMS processes. The role ensures the system supports compliant, efficient, and accurate data management for pharmaceutical operations.</p>
Responsibilities:
<ul><li>Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, stability program management and systems integration.
</li><li>Provide subject matter expertise on local and multi-site LIMS projects.</li><li>
Ensure system compliance with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.</li><li>
Build and maintain static and variable master data within LIMS.
</li><li>Write and execute validation protocol test scripts, including validation of LIMS subroutines, analyses and other code-based functionality.</li><li>
Serve as primary contact for troubleshooting LIMS issues and work to resolve in a timely manner. Collaborates with IT, the LIMS Vendor, and System Administrators to troubleshoot / resolve application and end-user issues.
</li><li>Implement and manage Change Controls and CAPAs to address LIMS related corrections and ensure changes or CAPAs are completed within assigned time frame.</li><li>
Develop and maintain LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.</li><li>
Maintain critical data and metadata within LIMS (including but not limited to specifications, protocols, test methods, storage locations, equipment, utility testing schedules, and stability protocols), aka Master Data.
</li><li>Identify workflow gaps and implement solutions to improve efficiency.</li><li>
Provide LIMS training to site personnel and support training efforts at other company locations as needed.
</li><li>As needed, provide coverage of Master Data building and end-user support for other company sites.
</li></ul>Qualifications / Skills::
<ul><li>Experience supporting and integrating lab applications in a regulated industry.</li><li>
Knowledge of 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.</li><li>
Strong understanding of LIMS and computer systems.</li><li>
Strong software troubleshooting experience.</li><li>
Strong understanding of laboratory processes, ideally in a FDA-regulated Pharma environment.</li></ul>
Qualifications:
<ul><li>Bachelor&rsquo;s or Master's Degree in Life Sciences, Computer Science, or a related field.</li><li>
3+ years of experience configuring and administering Laboratory Information Management Systems (LIMS)</li><li>
6+ years of laboratory experience in a GMP environment</li><li>
Experience building LIMS Master Data</li></ul></div>

Senior LIMS Administrator & Business Analyst (Hybrid)

Join Cambrex and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Cambrex

About Company

Chemist I, Quality Control

Senior LIMS Administrator & Business Analyst (Hybrid)