Data Review Specialist – Extractables and Leachable

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):
Masters 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
   

Remote Work :

No

Employment Type :

Full-time