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Summary
The QC Technician performs quality control analysis on finished products and incoming materials according to cGMP and SOPs. They perform routine GxP compliance and operational activities following Novartis quality standards, analyzing batches and incoming materials per cGMP rules and SOPs.
About The Role
This role requires working in rotating shifts, including night turns.
Major Accountabilities
* Perform analysis of batches following specific training.
* Conduct routine maintenance, cleaning, and microbiological verification of pharmaceutical QC equipment; support external personnel for extraordinary maintenance and qualification activities.
* Verify incoming and outgoing raw materials and materials.
* Execute calibration, verification, qualification, and validation activities of QC processes and equipment.
* Oversee QC sampling activities during manufacturing.
* Test raw materials and finished products, perform environmental monitoring and sterility QC testing, report results, and escalate non-conformances and deviations.
* Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow-up, and change control management.
* Participate in qualification and validation activities as needed.
* Prepare documents, records, and follow Good Documentation Practices.
* Assist in internal and external audits and inspections.
Minimum Requirements
* Degree in chemistry or biology is desirable.
* Experience in radiopharmaceutical companies is desirable.
* Fluent in Spanish and proficient in English.
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Seniority level
* Entry level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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