Scientist II- Quality Assurance

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Job description

Job Description

Under general supervision, performs work that is varied and may be somewhat difficult in character. Audits and monitors various aspects of Eurofins Advantar Laboratories, Inc. for compliance with Good Manufacturing Practices (GMP) or in support of Good Laboratory Practices (GLP) by performing essential audits and training.

This position will require working and interacting with different employees of the company. In addition, a detailed oriented and team player person is essential for this position due to high volume of work. Knowledge of electronic documentation systems is a plus as this person may be involved in the deployment of new Part 11 electronic systems and other supporting systems. Must have the ability to apply acquired knowledge of Good Documentation Practice (GDP) and GMP to daily tasks. Knowledge of cGMP, GLP, Eudralex Volume 4, and ISO regulations are a plus.

Essential Duties, Activities, and Responsibilities:

Applies GMP in all areas of responsibilities, as appropriate

Demonstrates and promotes company vision

Performs all QA functions in compliance with quality policy and regulatory requirements

Audits a variety of methodologies as applied to various stages of pharmaceutical development

Verifies accurate transcription of raw data into Reports, Certificate of Analysis, or Summary of Analysis

Reviews laboratory data and executed batch records against Advantar procedures

Follows and facilitates adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs

Performs internal laboratory audits and keep management informed of identified findings

Discusses compliance issues with responsible scientist, Project Director, or Area Management

Interacts with clients as necessary to maintain and grow the business

Regular attendance and punctuality

Keeps current with project review, closeout, and archival

Writes, formats, trains in Standard Operating Procedures and supports Quality Audits

Attends training programs as needed to satisfy regulatory requirements

Supports new quality initiatives and continuous improvements

Conducts all activities in a safe and efficient manner

Performs all other duties as assigned

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