Senior Specialist Data Review - Biologics (Large molecules)

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:   - 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, 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 - 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   Education/Experience (BMQ: Master’s degree in a science-related field with 15-17 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, Proteomics, Flow Cytometry, TEM, PCR, cell culture 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. 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