Process Monitoring and Data Analytics Specialist

5 days ago


Parsippany, New Jersey, United States SPECTRAFORCE Full time

Job Title: Process Monitoring and Data Analytics Specialist

Location: Hybrid (3 days onsite per week)

Duration: 12+ Months

Key Responsibilities:

  • Develop and implement commercial biologics Continued Process Verification (CPV) program strategies.
  • Support batch processing data collection and verification activities.
  • Author, review, and approve CPV protocols, reports, and present CPV data to Subject Matter Experts (SMEs).
  • Identify and implement improvements for data collection and management to enable quick and reliable data analysis.
  • Provide statistical expertise for global commercial process monitoring in compliance with ICH / Health Authority, QbD guidelines, and SOPs.
  • Assist in resolution of investigations doing statistical analysis.

Requirements:

  • 4+ years of relevant experience and a BS degree in a relevant scientific discipline.
  • 2+ years of relevant experience and an MS degree in a relevant scientific discipline.
  • Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire, and R.
  • Excellent technical writing skill.
  • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
  • Excellent troubleshooting skills and ability to solve complex technical issues.
  • Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
  • Extensive knowledge of industry practices.
  • Excellent verbal, written, and interpersonal communication skills.
  • Ability to effectively manage multiple projects/priorities.


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