Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The role of the quality assurance specialist is integral to the production of enzyme/protein products in adherence to GMP requirements. They are responsible for supervising and participating in various activities related to product quality, including conducting detailed assessments and ensuring that the final product meets the quality standards.

The responsibilities include the following:

Developing and maintaining quality assurance documents in compliance with ISO 13485 and GMP requirements. This involves preparing, updating, and reviewing these documents to ensure their accuracy and adherence to relevant standards.

Actively participating in the company's quality assurance processes, including resolving deviations and customer complaints. The quality assurance specialist plays a crucial role in identifying and addressing issues to maintain product quality and customer satisfaction.

Ensuring the effective implementation of risk management activities by either participating directly or providing guidance to the team.

Verifying and approving the accuracy of updated documents within the system. The quality assurance specialist performs detailed checks to ensure that all changes align with the established quality standards and regulatory requirements.

Printing and issuing protocols for serial production and analysis.

Coordinating training programs to ensure compliance with GMP requirements. This involves coordinating and facilitating training sessions for employees to improve their understanding of GMP principles and ensure consistent adherence to quality standards.

Preparing documents for product release. As part of the release process, the quality assurance specialist is responsible for preparing the required documentation. This involves compiling and organizing all necessary information to ensure a smooth and compliant release of products to the market.

Keys to Success:

Education

Bachelor’s degree (or higher) in molecular biology, chemistry, biochemistry or similar life sciences fields.

Experience

Work experience in a production or research department (would be considered as advantage).

Demonstrated experience on requirements of Quality Management System (ISO9001, ISO13485, CFR Part 820) and Good Manufacturing Practice (GMP).

Knowledge, Skills, Abilities:

English language communication skills both written and verbal.

Project planning and solid understanding of Excel, Word, Access, and quality management software.

High ethical standards to support a professional business code of conduct.

Well-versed in the development and execution of quality management systems. 

Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment. 

Work demeanor that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.

Values of Integrity, Intensity, Innovation, and Involvement.

We Offer:

The innovative environment of the rapidly growing international company.

Hard-working, encouraging working team and management with outstanding development possibilities to increase your potential.

An opportunity to be the part of a dynamic organization and work with experienced professionals.

Competitive salary range of €1983–€2971 gross, subject to experience and competence.

At Thermo Fisher Scientific, each one of our 120,000 extraordinary minds has a unique story to tell.

Apply today! http://jobs.thermofisher.com

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

Compensation

The monthly salary range estimated for this position based in Lithuania is €1 983,33–€2 970,83.