Data Review Specialist - Extractables and Leachable
Job Description
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
- 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
Additional Information
Key Candidate Attributes:
