About this role
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 practicesSupporting the continuous improvement of the Eurofins Quality System through review of regulatory updates, inspection findings, warning letters, and industry trendPerforming QA review and release of analytical reportsAssisting with the preparation of audit responses and regulatory correspondenceProviding 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 appropriateDemonstrate and promote the company visionRegular attendance and punctualityStay abreast with all regulatory guidance and provide updates to QA teamCompletion of any QA assigned activitiesOn-boarding training documentation preparationCore training of new hires which includes account set up, assigning SOPs, documentation test gradings, conducting ELN and LIMS classes, etc,Exception / Investigation writing 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
Abilities and/or Skills:
Honest, Dependable, Demonstrated Ability to Self-ManageDetail Oriented, Accurate, PreciseStrong Math SkillsStrong Organizational SkillsLogical Thinking, Good Reasoning AbilityStrong communication including verbal, writing, and presentation skillsDedication to quality, ethics, and customer serviceAbility to handle personal stressMental and emotional stability and maturityMotivation to excelShould be able to sit for long periods as per role requirementTeam Lead experience