Charles City - QC Stability Support Specialist
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 p r imarily r eview 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 task s as appropria
- High attention to detail
- P roficiency in a windows-based environment including word p rocessing, spreadsheet and data base programs
- Experience with chemical handling preferr
- High school degree or GED required
- cGMP knowledge required
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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