Auditor Quality Compliance
- Experience Level
- Experienced (non-manager)
Job Title: YRC01G – Quality Compliance Auditor (Good Clinical Practice and Pharmacovigilance focused)
The GCP/PV Quality Compliance Auditor supports the Company Quality Compliance department to ensure the Quality Management System goals and requirements are met. Responsible for ensuring the Company’s quality systems and procedures meet US and international regulatory requirements (e.g., FDA/CRF, GxP, EMA, HRA, EU GVP, GCP) as applicable for business. Performs all appropriate Quality Compliance tasks including supporting regulatory/client audits, performing internal, third-party supplier, REMS, and investigator site audits, and ensuring appropriate follow-up to completion. Facilitates the Company CAPA program, performs document review, and ensures Company policies and Standard Operating Procedures (SOPs) are updated within required timelines. Maintains appropriate quality documentation within the respective business unit. Performs other work, as appropriate. Travel as needed, expected 15-20%.
Specific job duties:
- Assists in development of annual audit plan(s) for Company and clients, where appropriate.
- Conducts internal, third-party supplier, REMS, and investigator site audits. Prepares audit report and tracks follow-up actions to completion.
- Conducts quality compliance document review for the Company and its programs.
- Participates in and supports client and regulatory audits. Assists in audit response development and follow-up actions to completion.
- Supports review of project-related and application validation documentation.
- Conducts REMS audits on behalf of clients. Develops audit report and performs follow-up to completion.
- Interacts with and supports client programs either directly or indirectly via individual programs.
- Identifies, evaluates, and addresses quality issues.
- Guides process owners in Root Cause Analysis and facilitates completion of Corrective and Preventive Action (CAPA) documentation.
- Performs CAPA effectiveness evaluations within a timely manner.
- Assists with development and maintenance of standard operating procedures.
- Conducts staff training as needed.
- Facilitates process improvement initiatives.
- Supports Quality Management Council activities.
Supervisory Responsibility: N/A
Desired Skills and Qualifications:
- Bachelor’s Degree required preferably in Life Sciences, Clinical, or Business area of study.
- 1 – 3 years quality assurance/compliance/auditing experience in regulated industry (e.g. pharma, medical device, food), GCP or PV industry experience preferred
- Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint.
- Excellent verbal presentation and written communications skills.
- Proven interpersonal and relationship building skills.
- Continual attention to detail in composing, typing, and proofing materials, establishing priorities and meeting deadlines.
- Proven skills in planning, analysis, and creative problem solving.
- Demonstrated ability to:
- Always be honest with a high level of integrity.
- Communicate effectively and professionally across all levels of the organization, with clients/sponsors, and with regulatory auditors.
- Manage multiple tasks and competing priorities in accordance with business needs.
- Be a team player who motivates and educates other team members.
- Work independently under limited supervision.
- Translate technical language to lay audiences.
- Be detailed oriented.
- Ensure confidentiality and discretion.
- Working knowledge of applicable regulations and quality best practices.
- Knowledge of using teleconference and videoconference programs (i.e., WebEx, Microsoft Teams, Skype).
- Preferred audit experience in conducting and hosting internal, vendor, client, and regulatory audits.
- Preferred experience with Corrective Action Preventive Action (CAPA) documentation including Root Cause Analysis, Action Plan Development, and CAPA Effectiveness Assessments.
- Preferred experience with client and/or project management.
- Preferred certification, Certified Quality Auditor (CQA).
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visiting