Senior QA Specialist

Company Description

Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.

In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.

Job Description

Position Summary:

This role supports Quality Assurance operations by ensuring compliance with regulatory requirements, corporate quality standards, and data integrity expectations. Responsibilities include

• Coordinating and documenting training for new employees on electronic laboratory systems (ELN, LIMS), Quality Management Systems (QMS), and documentation practices
• Supporting the continuous improvement of the Eurofins Quality System through review of regulatory updates, inspection findings, warning letters, and industry trend
• Performing QA review and release of analytical reports
• Assisting with the preparation of audit responses and regulatory correspondence
• Providing support for quality assurance, data review, and other compliance-related activities as needed to maintain operational excellence and regulatory compliance.

Essential Duties and Responsibilities: 

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrate and promote the company vision
• Regular attendance and punctuality
• Stay abreast with all regulatory guidance and provide updates to QA team
• Completion of any QA assigned activities
• On-boarding training documentation preparation
• Core training of new hires which includes account set up, assigning SOPs, documentation test gradings, conducting ELN and LIMS classes, etc,
• Exception / Investigation writing

Qualifications

Basic Minimum Qualifications (BMQ): 

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Education/Experience (BMQ):

Master’s degree in a science-related field with at least 7-10 years of experience in Bio/Pharmaceutical  drug product/substance testing with knowledge of regulatory requirements and some data review responsibilities

Experience of QA department, USP/EP compendia, laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred

Additional Information

Abilities and/or Skills:

• Honest, Dependable, Demonstrated Ability to Self-Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational Skills
• Logical Thinking, Good Reasoning Ability
• Strong communication including verbal, writing, and presentation skills
• Dedication to quality, ethics, and customer service
• Ability to handle personal stress
• Mental and emotional stability and maturity
• Motivation to excel
• Should be able to sit for long periods as per role requirement
• Team Lead experience