Job Description

The Senior Quality Assurance (Sr. QA) Specialist of the Quality Assurance Group coordinates New Product Introduction (NPI) process, prepares and updates quality assurance documents, checks documentation related to GMP processes, participates in the resolution of deviations, non-conformities and complaints.

The Sr. Quality Assurance Specialist is directly related to the activities performed in aseptic production.

The Senior QA Specialist replaces the Quality Assurance Manager on vacation, illness, business trips, etc.

Key responsibilities:

• Coordinates introduction of the new GMP products into manufacturing facilities, prepares and updates quality assurance documents according to ISO 13485 and GMP requirements,

• Participates in quality assurance activities (investigates unplanned deviations, major change process supervision)

• Coordinates GMP risk management processes: Ensures the implementation of risk management activities by participating in or advising the risk management team on risk assessment. Monitors risk control activities.

• Coordinate initial and following trainings for employees working under GMP requirements

• Checks and approves batch production, analysis, environment monitoring protocols, forms related to GMP procedures. Prepares documents required for batch release, provides information to the QA Group Manager.

• Ensures the confidentiality of information acquired at work.

Provides proposals related to the improvement of the functions performed and the activities of the unit. Sr. Quality Assurance Specialist ensures the confidentiality of information acquired at work.

Requirements for qualification / Education / Experience:

Main qualification, education and Experience requirements for position are:

• University Bachelor's or Master's degree in molecular biology, chemistry, biochemistry, genomics, or similar fields.

• Excellent English and Lithuanian language skills in verbal and written communication.

• Experience in providing quality support for GMP activities, specifically in the context of the New Product Introduction (NPI) process

• Knowledge of ISO 9001, ISO 13485 quality standards. Understanding of GMP requirements.

The total base pay range is €31,500.00 to €42,000.00.

This translates to a monthly salary range of approximately €2,625.00 to €3,500.00 before taxes.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is €31,500.00–€42,000.00.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.