Principal Data Review Specialist – Large Molecules and Microbiology

  • Full-time

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.

Job Description

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
     
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