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.
Role Description
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Stay abreast with current regulatory guidance’s
- Review complex routine and non-routine data (for five or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations
- Communication in writing and in person with laboratory personnel in an intelligent and clear manner
- 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 complex routine and non-routine data scientific data according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations
- Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, 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 and complex problems in professional area; evaluate existing systems; develop new systems to improve efficiency
- 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 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
- Performs other duties as assigned
Education/Experience (BMQ):
Master’s degree in a science-related field with at least 10 years of experience in Bio/Pharmaceutical Chemistry drug product/substance testing with thorough knowledge of regulatory requirements and data review responsibilities.
Experience with analytical techniques such as Chromatography (HPLC/UPLC, GC, IC…etc.), LC-MS/MS, Spectroscopy (UV, IR, NMR), knowledge of USP/EP compendia, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred.
Abilities and/or Skills:
· Coaching and mentoring of the junior team members
· Honest, dependable, demonstrated ability to self-manage
· Detail oriented, accurate, precise, strong organizational skills
· Strong math skills, logical thinking, good reasoning ability
· Strong communication including verbal, writing, and presentation skills
· Dedication to quality, ethics, and customer service
· Ability to handle personal stress, mental and emotional stability
· Tactful, ability to follow directions, responsibility
· Motivation to excel
· Should able to sit for long periods as per role requirement