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