Specialist Data Review – MD-MV Analytical Chemistry

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

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 4-7 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 (HPLC/UPLC, GC, IC…etc.), knowledge of USP/EP compendia, and laboratory software applications such as Waters Empower software, 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