Senior Specialist Data Review - Biologics (Large molecules)
Eurofins
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 6-10 years of experience in Bio/Pharmaceutical Chemistry 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
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