Principal Data Review Specialist – Large Molecules And Microbiology

Company Description Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries From food and pharmaceuticals to environmental and cosmetic products Eurofins ensures safety authenticity and accuracy With a global presence and over 900 laboratories Eurofins is a leader in food environmental pharmaceutical and cosmetic product testing as well as in genomics clinical studies support and other specialized diagnostic testing Position Summary Ensuring that the client receives quality data by reviewing laboratory data for accuracy clarity and adherence to GMP and or GLP regulations Essential Duties and Responsibilities Leading the team of 8-10 individuals from large molecules and microbiology domain 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 methodology QC sample data 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 Attention to details Works in collaboration Performs other duties as assigned Applies GMP GLP in all areas of responsibility as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures 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 Master s degree in a science-related field with 10-12 years of experience in Bio Pharmaceutical drug product substance testing with knowledge of regulatory requirements Theoretical Practical experience with analytical techniques such as Ligand binding assays ELISA Gel electrophoresis Next gen sequencing Flow Cytometry TEM PCR qPCR RT-PCR cell culture banking maintenance prep water Testing microbial limit testing endotoxin testing sterility testing and environmental monitoring and cell-based assays such as reporter gene cell signaling and cell proliferation etc Knowledge of USP EP compendia and laboratory software applications such as 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