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Sr Auditor, Qa

5+ years
Not Disclosed
10 Dec. 1, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Senior Auditor, QA position at Syneos Health is a vital role responsible for conducting audits, supporting regulatory inspections, and ensuring compliance with GxP (Good Clinical Practice) standards. This role is home-based in the United States, with moderate travel required (up to 50%).


Position Overview

  • Location: US Home-Based
  • Job ID: 24006337
  • Updated: November 28, 2024

This role requires a Bachelor’s degree in a science or healthcare field and 5 years of experience in GxP quality assurance auditing within the pharma or CRO industry. The Senior Auditor will be responsible for auditing computer systems, performing for-cause audits, and preparing for both customer audits and regulatory authority inspections.


Key Responsibilities

  1. Syneos Health Audits:

    • Plan and conduct assigned audits.
    • Write clear audit reports and issue findings to auditees and relevant management.
    • Review responses to audit findings for appropriateness and completeness.
    • Close assigned audits.
  2. Customer Audits/Inspections:

    • Prepare for and support customer audits and regulatory authority inspections.
    • Serve as a Lead or Assisting Auditor during team-based Syneos Health audits.
  3. Training and Mentorship:

    • Train and mentor less experienced auditors in QA processes.
    • Provide guidance on audit processes and procedures.
  4. Supervision and Compliance:

    • Work with minimal supervision on day-to-day tasks and assignments.
    • Ensure audits comply with GxP standards and regulatory requirements.
  5. Additional Responsibilities:

    • Write or revise QA Standard Operating Procedures (SOPs) and Work Instructions (WIs).
    • Perform other work-related duties as assigned.

Qualifications

  • Education:

    • Bachelor’s degree in science, healthcare, or a related field.
  • Experience:

    • 5 years of experience in GxP quality assurance auditing in the pharma or CRO sector.
    • Experience conducting multiple types of audits (e.g., vendors, process, computer system validation).
    • Experience in supporting customer audits or regulatory inspections is a plus.
  • Knowledge and Skills:

    • Strong knowledge of GxP regulatory requirements.
    • In-depth understanding of Computer Systems Quality Assurance.
    • Familiarity with ISPE GAMP 5 concepts is preferred.
    • Proficient in Microsoft Office and SharePoint.
    • Ability to handle multiple tasks and meet deadlines in a dynamic environment.
    • Strong organizational, presentation, and communication skills.
  • Travel:

    • Moderate travel required (up to 50%).

Why Syneos Health?

Syneos Health offers a dynamic work environment that prioritizes career development, engagement, and cultural diversity. The company promotes its Total Self culture, where employees are encouraged to be their authentic selves, fostering a supportive and inclusive environment. Syneos Health works with 94% of all Novel FDA Approved Drugs and supports 95% of EMA Authorized Products, contributing significantly to the biopharmaceutical industry.


Additional Information

  • Salary & Benefits:
    • Salary details were not specified, but the company offers comprehensive benefits, including healthcare, 401k, stock purchase plans, and flexible paid time off (PTO).

This position offers an exciting opportunity to lead audits and work on impactful projects in the biopharmaceutical industry, especially within a globally recognized organization.