Sr Auditor, Qa

Syneos Health

5+ years

Not Disclosed

Remote, USA

10 Nov. 29, 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

Senior Auditor, Computer Systems Quality Assurance

Company: Syneos Health
Location: Hybrid (Remote with up to 50% travel)

About Syneos Health

Syneos Health is a leading global biopharmaceutical solutions organization, known for accelerating customer success through innovative clinical, medical affairs, and commercial solutions. The company prioritizes customer and patient needs, constantly streamlining processes to improve collaboration, efficiency, and outcomes.

Why Join Syneos Health?

Career Development: The company provides ample opportunities for professional growth, training, and peer recognition.
Inclusive Culture: Syneos Health fosters a workplace where everyone can be their authentic selves, encouraging diversity in thought, culture, and perspectives.
Global Impact: With a presence in 110 countries and over 29,000 employees, Syneos Health is committed to making a difference in the world through clinical research.

Role Overview

The Senior Auditor in Computer Systems Quality Assurance will be responsible for planning and executing audits to ensure compliance with regulatory requirements. This includes performing audits related to Good Manufacturing Practice (GxP) and Computer Systems Validation, as well as supporting customer audits and regulatory inspections. You will also mentor less experienced auditors and participate in developing and updating QA Standard Operating Procedures (SOPs).

Key Responsibilities

Syneos Health Audits

Audit Planning and Execution: Plan and conduct assigned audits, including performing For Cause audits and issuing clear, actionable audit reports.
Audit Report Review: Review responses to audit findings, ensuring appropriateness and completeness.
Audit Closure: Ensure the timely closure of assigned audits.

Customer Audits/Inspections

Audit Support: Prepare and support customer audits and regulatory authority inspections, ensuring smooth execution and compliance with all relevant guidelines.

Audit Leadership and Training

Lead Auditor: Serve as the Lead Auditor for Syneos Health audits, overseeing the audit process from start to finish.
Mentorship: Mentor and train junior auditors, sharing expertise and helping them develop their skills.

Additional Responsibilities

SOP Development: Write, review, and update QA Standard Operating Procedures (SOPs) and Work Instructions (WIs) as needed.
Other Duties: Assist with other work-related tasks, as assigned, to support the overall QA function.
Moderate Travel: Travel may be required up to 50% of the time, depending on audit schedules.

Qualifications

Required Experience & Skills

Bachelor’s Degree in a science or healthcare-related field or equivalent.
Experience: At least 5 years of experience in GxP quality assurance auditing, particularly in the Pharma or CRO sector.
Audit Experience: Demonstrated experience conducting various audit types (e.g., vendors, process, computer system validation).
Knowledge of GxP Requirements: In-depth understanding of GxP regulatory requirements and Computer Systems Quality.
Preferred Knowledge: Familiarity with ISPE GGAMP5 concepts is a plus.
Technical Proficiency: Strong computer literacy, including proficiency with Microsoft Office and SharePoint.
Communication Skills: Excellent written and verbal communication skills, with the ability to prepare clear, accurate reports.
Multitasking Ability: Able to manage multiple tasks and meet deadlines in a dynamic environment.
Organizational Skills: Strong organizational skills and attention to detail.
Interpersonal Skills: Strong interpersonal skills with cultural sensitivity to interact effectively with diverse stakeholders.

Compensation & Benefits

Syneos Health offers a competitive benefits package, including:

Salary Range: Competitive, based on experience.
Other Benefits: Health benefits (Medical, Dental, Vision), 401(k) with company match, and performance-based bonuses.
Flexible Time Off: Paid time off (PTO), sick time, and flexibility to balance work and life.

Apply Now to become part of a dynamic, globally focused company, driving forward quality assurance in clinical research.

Syneos Health is committed to diversity and inclusion, welcoming applicants from all backgrounds to apply.

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