Senior Data Review Specialist – Chemistry (LC-MS/MS Data Review)

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.

Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains

Applies GMP/GLP in all areas of responsibility, as appropriate

Demonstrate and promote the company vision

Regular attendance and punctuality

Review simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations

Communication in writing and in person with laboratory personnel in an intelligent and clear manner

Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process

Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, and other subjective review based on testing performed; perform complex calculations to verify results

Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology

May serve as technical advisor for analysts with regard to QA/QC of data

Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area

Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees

Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas

Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns

Conducts all activities in a safe and efficient manner

Performs other duties as assigned

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.

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

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