Job Description

Internal Auditor
Job Number: 21-15849
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Internal Auditor for our client in Warren, NJ.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Leads internal GMP audits of assigned departments, assess compliance with regulatory and Client requirements; identify compliance risks and drive concurrence regarding their severity.

Responsibilities:
  • Audit Planning and Schedule Development:
    • Provides input to the risk assessment of assigned auditable departments to identify the risk-based audit frequency for each entity
    • Coordinates annual audit schedule.
  • Audit Preparation:
    • Reviews auditees audit history and other supporting information; provides to audit team members (if applicable) for use in audit preparation activities
    • Defines the scope and depth of the audit and drafts the agenda
    • Issues audit agenda and requests required pre-audit information from the auditee
    • Leads pre-audit team meeting, reviews pre-audit information with the audit team
  • Audit Conduct
    • Conducts opening meeting with the auditee, auditee SMEs and audit team (if applicable), includes presentation of the agenda and agreement on scope and timelines.
    • Manages the execution of the audit
    • Ensures the audit team uses relevant audit guidelines and that the team executes the defined audit agenda
    • Ensures observations are documented and evidence of deficiency is obtained.
    • Escalates potentially or confirmed critical observations to Site Quality
    • Hosts close-out meeting to communicate audit outcome with auditee and audit team.
  • Audit Reporting:
    • Assigns criticality levels to all observations noted and drafts the final audit report.
    • Provides draft audit report to Site QA Management for review prior to incorporation into the Electronic Document Management System (EDMS).
    • Approves final audit reports and obtains Site QA Management Approval in the EDMS.
  • Audit Follow-Up:
    • Reviews and tracks all observation responses and observation CAPAs to closure.
    • Issues Audit Certificates
  • Continuous Improvement:
    • Generates audit metrics as required. Presents audit outcome at month Site Quality Council Meetings.
    • Supports QA Compliance Group as needed during Client Corporate Audits of the site.

Qualifications:
  • Minimum of B.S. or the equivalent combination of relevant education or professional experience
  • 5-7 years of relevant GMP pharmaceutical/biotechnology industry experience, including at least 2 years of GMP auditing experience
  • ASQ CQA certification or comparable certification required
  • 5-7 years of experience
  • B.A, B.S Biology Chemistry (Preferred)

Skills:
  • Strong knowledge of core GMP auditing processes
  • Broad knowledge of all relevant laws / regulations and deeper knowledge or relevant laws / regulations in multiple GMP/GDP area(s); ability to translate regulations into operational requirements
  • Organization and planning abilities with attention to detail
  • Basic understanding of risk management and ability to evaluate an organizations risk exposure
  • Proficient in Microsoft Office
  • Possesses working knowledge of Deviation and CAPA Management and change control
  • Generate and present audit/quality metrics via PowerPoint/Excel.

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact: 
Kaeth Barawid
Kaeth.barawid@eclaro.com
3322094548
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 

Application Instructions

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