Data Review Specialist - Extractables and Leachable

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 pharma / science-related field with 2-6 years of experience in Bio/Pharmaceutical or Medical Device Analysis testing with knowledge of regulatory requirements.
Experience with chromatography and mass spectrometry analytical techniques (HPLC, GC, LC/MS, GC/MS) knowledge of USP/EP compendia, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred.

Additional Preferences:

• Experience with Agilent MassHunter software
• Experience with extractables and leachables testing
  

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