Senior Specialist Data Review – MD-MV Analytical Chemistry

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: 

• 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
• Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs
• Gain a technical understanding of the techniques in which review is being performed
• Use MS Windows applications such as EXCEL, Word, Access, Outlook email
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Qualifications

Education/Experience (BMQ):

Master’s degree in a science-related field with 7-10 years of experience in Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements.

Theoretical / Practical experience with analytical techniques such as pH meter, Spectroscopy (UV, IR,), Chromatography assay/imps (HPLC/UPLC, GC, IC…etc.), Analytical method validations data review, knowledge of USP/EP compendia, ICH guidance, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred.

Additional Information

Abilities and/or Skills:

• Honest, Dependable, Demonstrated Ability to Self-Manage
• Detail Oriented, Accurate, Precise
• Strong Math Skills
• Strong Organizational 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 and maturity
• Motivation to excel
• Should be able to sit for long periods as per role requirement
• Team Lead experience