QA Auditor II

Syneos Health • Princeton, NJ

8d

About The Position

QA Auditor II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities SUMMARY Conduct GLP/GCLP lab facility and data audits to assess compliance with applicable regulations, company policies, standard operating procedures (SOPs) and work instructions (WIs), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs.

Requirements

• Requires a Bachelor’s degree in the science/health care field or equivalent with moderate experience in GLP/GCLP quality assurance auditing.
• Good knowledge of GxP regulatory requirements.
• Knowledge of medical and technical terminology related to the audit types to be conducted.
• Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint; TrackWise) proficiency).
• Able to handle multiple tasks to meet timelines in a dynamic environment.
• Strong organizational, presentation and interpersonal skills.
• Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
• Ability to negotiate and provide constructive feedback.
• Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation.

Responsibilities

• Plans and conducts assigned BioA GLP/GCLP lab facility and data audits.
• Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
• Reviews responses to audit findings for appropriateness and completeness.
• Closes assigned audits.
• Prepares for and hosts/manages customer audits.
• Assists senior QA personnel in hosting or supporting Regulatory Authority Inspections.
• Requires some instructions on day-to-day work and new assignments.
• Performs other work-related duties as assigned.

Benefits

• The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.
• Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work.
• Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level