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Senior Analyst, Biometrics Quality & Compliance (Remote flexibility)

Company:
Artech Information Systems
Location:
Massachusetts, United States
Posted:
September 10, 2018

Description:

Job Description:

Title: Senior Analyst, Biometrics Quality & Compliance

Job Id: BIIBJP00009644

Location: Cambridge, MA (Remote flexibility for a strong candidate)

Period: 12 months

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

Specifically looking for GCP & Biometrics experience

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 Education Requirements: Bachelor’s degree required

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