Operations Analyst
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Operations Analyst
Ref No.: 18-02967
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 07/02/2018 to 07/05/2019
TItle: Operations Analyst
Location: Cambridge, MA
Duration: 12 Months Contract


Responsibilities:
  • Lead Biometrics quality issue investigation (e.g. root cause analysis) & remediation
  • Provide support to Biometrics staff with quality activities including CAPAs, process deviations & other compliance related items
  • Support for Inspection Readiness and Regulatory Inspections
  • Assess quality risks & assist teams in creation of quality indicators at the study & process level
  • Lead end to end Biometrics process compliance quality checks
  • Conduct capability assessments of Biometrics vendors including CROs and 3rd Party Vendors (ePRO, MRI, etc)
  • Other quality departmental support as needed


Minimum Experience Requirements:
  • 7-10 years relevant work experience in GCP Quality; Biometrics experience a plus
  • Expertise in global industry regulations and best practices (e.g. Data Integrity, GCP, 21 CFR Part 11)
  • Experience with regulatory inspections
  • Experience with Quality Issue Management (e.g. CAPAs)
  • Deep understanding of drug development and biopharmaceutical industry
  • Strong project management skills; high attention to detail with proven ability to manage multiple, competing priorities & ensure follow through to closure
  • Ability to work effectively across functions and levels; excellent negotiation and problem-solving skills

Minimum Education Requirements: Bachelor's degree required

Must Haves:
  • Experience with regulatory inspections/audits
  • Experience with Quality Issue Management (e.g. CAPAs),
  • GCP Quality experience, DM, Stats
  • Stat Programming experience a plus