QC Analyst (Laboratory Operations Analyst)
Laboratory Operations Analyst (QC Analyst)
(12-Month Fixed Term Contract)
Job Purpose
The primary purpose of the Laboratory Analyst is to analyze raw materials, in-process, and finished products, as well as stability samples, according to relevant specifications for development products. The role also involves documenting and reporting results in accordance with good laboratory practices.
Key Responsibilities
* Perform duties primarily in the QC Laboratory, following company safety policies, cGMP, and cGLP guidelines.
* Receive and log samples into the laboratory system.
* Analyze raw materials, in-process, finished products, and stability samples as per specifications.
* Conduct analytical method validations and investigational testing as directed.
* Record results accurately and promptly.
* Achieve the Right First Time KPI concerning analyst documentation.
* Review co-worker/analyst documentation (Buddy System).
* Ensure compliance with all Quality Systems daily.
* Label laboratory reagents and samples correctly.
* Troubleshoot erroneous analytical data and participate in lab investigations.
* Maintain up-to-date SOPs and specifications in compliance with regulations.
* Train other laboratory staff as needed.
Qualifications / Experience / Skills
* BSc in a science-related discipline.
* Minimum of one year working experience in a cGLP laboratory.
* At least 12 months HPLC experience is mandatory.
* Ability to troubleshoot and resolve analytical issues with corrective actions.
* Strong analytical data review skills with high attention to detail.
* Excellent interpersonal skills for internal and external collaboration.
* Experience in a cGMP environment (HPRA and FDA approved) is desirable.
About Helsinn Birex Pharmaceuticals
We are a global pharmaceutical company specializing in supportive care, dedicated to improving the health and quality of life for patients with cancer and chronic diseases. For more information, visit our website.
Skills: GLP, GMP, HPLC, Dissolutions, GC
Benefits: Performance Bonus, Parking with EV Charger, Health Insurance, Flex Time, Subsidized Canteen
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Medical and Diagnostic Laboratories
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