Senior QA Specialist

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):

Masters 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

Remote Work :

No

Employment Type :

Full-time