Technician QC Physico Chemistry

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Aperèc in Switzerland is seeking a QC Technician Physico Chemistry to perform QC analyses in support of production release and stability testing, and to actively participate in new product introductions and method transfers.

You will author, review and maintain SOPs and work instructions, support equipment qualification and calibration, manage QC consumables, and ensure compliance with GMP and company standards; weekend work may be required.

Qualifikationen

• CFC or higher degree in analytical chemistry/biochemistry.
• At least 5 years’ experience in biotech/pharma/chemical environments.
• Hands-on GMP and QC experience.
• Strong knowledge of analytical method transfer and validation.
• Solid knowledge of spectroscopic, HPLC, CE and ELISA techniques.
• Proficiency with Empower or Soft Max PRO.

Aufgaben

• Performs QC analyses to support raw materials, production release and stability plans.
• Reviews analytical data and documents.
• Acts as a key user for QC software and method setup.
• Performs basic lab tasks (buffer prep, waste disposal, lab cleaning).
• Contributes to method transfer and problem resolution.
• Authors, reviews and maintains SOPs and work instructions.
• Supports equipment selection, qualification and commissioning.
• Manages QC consumables and standards supply.
• Supports calibration/maintenance of equipment and supplier relationships.
• Ensures samples are efficiently managed and compliant with requirements.
• Raises, investigates and closes deviations and non-conformances.
• Upholds business integrity and legal compliance.

Kenntnisse

Autonomy

Excellent team spirit

Good writing skills

French fluent

English proficiency

Ausbildung

CFC or higher degree in analytical chemistry/biochemistry

Tools

Empower

Soft Max PRO

Jobbeschreibung

Aperèc

The QC Technician Physico Chemistry performsQC analysis to support production and release of drug substance, stability testing. The QC Technician Physico Chemistry also actively participate to new product introduction and method transfer. He/she also authors the analytical procedures and the general QC procedures.

Essential Functions of the Job (Key responsibilities)

• Performs the QC analysis to support raw materials, production release and stability plan of drug substance (HPLC, UPLC, CGE, pH, FTIR, Osmolality, Protein Concentration or ELISA tests, appearance).
• Performs the review of analytical data.
• Act as a a key user for QC equipment software and method setup.
• Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.).
• Proactively propose problem resolutions
• Efficiently contribute to method tech transfer.
• Author, review and maintain Standard Operating Procedures, Work Instructions, and other quality control documents.
• Supports selection, purchase and commissioning of new equipment.
• Supports management supply of QC consumables, reagents and standards.
• Supports maintenance/calibration of equipment and keeps relationship with suppliers.
• Contribute to the efficient management of samples.
• Proactively propose problem resolutions.
• Raise, investigate and close events, deviations and non-conformances.
• Contribute positively to a strong culture of business integrity and ethics.
• Act within compliance and legal requirements as well as within company guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• CFC or higher degree in analytical chemistry/biochemistry
• At least 5 years’ experience in the biotech, pharmaceutical or chemical environment
• Hands-on experience in a GMP environment and a Quality Control environment.
• Good knowledge of analytical method transfer and analytical method validation.
• Solid knowledge in spectroscopic, HPLC, CE and ELISA techniques.
• Solid knowledge of Empower or Soft Max PRO.
• Good writing skills.
• Excellent team spirit.
• Autonomy
• French: Native or Fluent
• English: Good knowledge
• Knowledge of most common office software.
• Work the weekend may be required.