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Stability Support Specialist

3 months ago

Saint Charles, Missouri, United States Cambrex 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
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

Reporting to Stability Coordinator, the Stability Support Specialist will primarily review draft stability protocols, generate or review data tables, and assist in setting stability studies

Responsibilities

Review draft stability study protocols for accuracy and completeness. Track stability study pull due dates and pull all necessary samples for submission to testing personnel within the required timeframe. Maintain stability chamber inventories. Consolidate and transcribe information into data tables at the conclusion of each testing timepoint. Review stability data tables generated by other department personnel for accuracy and completeness. Assist the Stability Coordinator with setting stability studies (aliquoting materials, preparing labels, preparing containers, etc.). Dispose of unused stability materials at the conclusion or cancelation of a study. Perform stability chamber temperature mapping. Assist with quarterly CS stability inventory. Support the Stability Coordinator with any other department related tasks as appropriate.

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

High school degree or GED required cGMP knowledge required High attention to detail Proficiency in a windows-based environment including word processing, spreadsheet and database programs Experience with chemical handling 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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