Auditor / Senior Auditor, Customer Interface

Quality Assurance Morrisville, North Carolina


Description

Position at Premier Research



Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

 We’re looking for an exceptional Auditor / Senior Auditor, Customer Interface to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

 At Premier Research, we are science-minded and heart-centered. Join us.

The Auditor / Senior Auditor, Customer Interface is responsible auditing activities in order to assure that the systems, processes and performance of Premier Research comply with applicable laws, regulations, Standard Operating Procedures (SOPs), protocols and guidelines, and meet Sponsor and Premier Research requirements. This role manages and supports audits and mentors members of the team as required. These activities drive assurance that the systems, processes and performance of Premier Research comply with applicable laws, regulations, SOPs, protocols and guidelines, and meet regulatory requirements.

POSITION SUMMARY:

The Auditor / Senior Auditor, Customer Interface is responsible auditing activities in order to assure that the systems, processes and performance of Premier Research comply with applicable laws, regulations, Standard Operating Procedures (SOPs), protocols and guidelines, and meet Sponsor and Premier Research requirements. This role manages and supports audits and mentors members of the team as required. These activities drive assurance that the systems, processes and performance of Premier Research comply with applicable laws, regulations, SOPs, protocols and guidelines, and meet regulatory requirements.

ROLE RESPONSIBILITIES:

· Organizes and hosts Business Development, Sponsor Qualification and Routine Sponsor audits to support global operations (including preparation of audit plans, audit checklists, audit reports and certificates)

· Manages complex audit activities and operational team readiness 

· Acts as Point of Contact (POC) for Hosting activities (pre and post award)

· Assist with cross-training and/or supervision of auditors

· Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation.

· Completes audit reports by documenting audit findings.

· Communicates audit findings by preparing a final report; discussing findings with auditees.

· Complies with federal, state, and local security legal requirements by studying existing and new security legislation; enforcing adherence to requirements; advising management on needed actions.

· Prepares special audit and control reports by collecting, analyzing, and summarizing operating information and trends.

· Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

· Contributes to team effort by accomplishing related results as needed

· Ability to travel up to forty percent (40%) of time

REQUIREMENTS:

· Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience

· BS/BA and 5-8 years specialized GxP experience in auditing (i.e. Sponsor, site, or vendor audits), or 8+ years relevant experience

· 2 years’ experience hosting audits (Sponsor or Regulatory)

· Ability to interpret controlled documentation (i.e. protocols, validation documents, manufacturing records and data)

· Experience with electronic data management systems preferred

· Demonstrated ability to independently review the majority of the following: databases, trial master files, investigator sites, statistical/clinical study reports, vendors, manufacturers, master batch records, device history files, laboratories, system validation documentation

· Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations

· Experienced PC user proficient with Microsoft Word and familiar with MS Excel and MS PowerPoint

· Excellent oral and written communication of the English Language

· Excellent organizational, interpersonal and communication skills 

· Excellent team player, collaborative and be effective within the quality team and  build strong relationships across the organization