Senior Data Review Specialist – Chemistry

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 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 Essential Duties and Responsibilities 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 Qualifications 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 Experience with analytical techniques data review such as Chromatography HPLC UPLC GC IC etc knowledge of analytical method validation USP EP compendia and laboratory software applications such as Waters Empower software LIMS Electronic Notebook is preferred Additional Information Key Candidate Attributes Self-motivation excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills oral and written Organizational ability and good judgement Science background education and or laboratory experience Strong Math Skills Logical Thinking Good Reasoning Ability Motivation to excel Coaching mentoring of peers