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Clinical Quality Systems Specialist

LanceSoft Inc

  • Nutley, NJ
  • 3 days ago
  • $53.57–$55 Per Hour

Highlights

The Clinical Systems Quality (CSQ) professional will work closely with the CQA - CSQ lead to deliver on internal validation efforts and audits vendors and computerized systems. Essential Functions Participate in computer systems and vendor audits for review of their validation (fit-for-purpose) and data lifecycle controls.

Numbers & Facts

LocationNutley, NJ
IndustryStaffing/Employment Agencies
Salary$53.57–$55 Per Hour
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttp://www.lancesoft.com/

Description

The Clinical Systems Quality (CSQ) professional will work closely with the CQA - CSQ lead to deliver on internal validation efforts and audits vendors and computerized systems.

Essential Functions
  • Participate in computer systems and vendor audits for review of their validation (fit-for-purpose) and data lifecycle controls.
  • Review CAPA and verification of CAPAs of system and vendor audits.
  • QA Representative for internal validation efforts.
  • Act as liaison to the business for guidance and consultancy on software validation fit for purpose .
  • Support health authority audits/inspections for inspection readiness.

Requirements
  • Bachelor s degree in associated functional disciplines including IT, Data Sciences and others.
  • Software development familiarity with both Agile and Waterfall methodology.
  • Minimum 7 years' experience Computerized System Validation (CSV) experience
  • Minimum 5 years' experience in Pharmaceutical industry or similar.
  • Minimum 3 years' experience Vendor / Computerized System Validation (CSV) Auditing experience
  • Knowledge of ICH GCP, clinical trial methodology, and specific knowledge of software validation regulations/guidance (including 21 CFR Part 11)
  • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.

About Company

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

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