20 days old

Clinical Senior QA Auditor

Kelly Services
Farmingdale, NY 11735
**Senior Auditor, QA**

**_Central or East Remote (Direct Hire)_**

Kelly Science and Clinical is hiring direct permanent Sr Quality Assurance Auditors for one of the largest global CROs in the world. This person can work from home (remote) within the central or east coast time zones. We are looking for strong GCP Investigator Site Auditors to join their team and grow with the company.

**Job Description:**

+ Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to conducting contracted/billable internal and vendor audits, documentation review and CAPA management.

+ Conduct departmental and staff training regarding clients quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.

+ Escalate quality and compliance issues to Q&C Line Management and relevant clients functions as appropriate.

+ Liaise with clients and operational staff on quality aspects (related to billable audits) which may include attendance at meetings, oral presentations, and audits.

+ Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate.

+ Have a thorough knowledge of all relevant SOPs, with ICH-GCP and relevant regulations and guidelines.

+ Understand key business drivers; uses this understanding to accomplish own work.

+ Assume additional responsibilities, which are directed by the Q&C Manager or higher.

+ Recognize, exemplify, and adhere to clients values which center around our commitment to People, Clients and Performance.

+ If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.

+ As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

+ Other duties as assigned. Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.

**Auditing Responsibilities:**

+ Plan and conduct regular billable/contracted internal audits, study/project audits (including standalone work), for cause audits, vendor, and sub-contractor audits.

+ Report the results of the audit and any relevant findings and track them into the systems as requested.

+ Review audit responses by the auditees. Follow up all outstanding replies and escalate issues to the relevant management for action.

+ Assist the Q&C management with the development of the internal billable audit schedule.

+ Train QA auditors and provide a standard for auditing to inexperienced or less experienced colleagues.

+ Operates under moderate supervision and direction and makes decisions frequently that have a direct impact upon the local external and internal audit schedule and the resource allocation for audits within the local department.

+ Ensure that the clients QMS/ tracking system is updated with the appropriate information and documentation.

+ Follow-up of CAPA plans to ensure actions are completed on time and the evidence available are adequate.

+ Determine effectiveness check requirements for responsible CAPA, define the effectiveness check plan, track, and complete the effectiveness checks as required, determine the outcome and inform operations and Q&C management accordingly.

+ Assist with the review of effectiveness check plans and effectiveness check outcomes for more junior QA auditors.

+ Assist Q&C Management / Director with oversight of open CAPAs (billable audits), trending and analysis of CAPAs and metrics reporting.

**Qualification Requirements:**

+ Minimum of 2 years of Site Audit experience

+ Must have CRO and Sponsor Experience

+ Must have Clinical Audit experience within GCP Auditing

+ Medical background (Nursing) or BS degree is preferred

+ Ability for travel (up to 35%) domestic and/or international, on occasion and this may increase based on business needs

+ Ability to work from home within Central or East Coast time zones

+ Must be vaccinated


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-07-25 Expires: 2022-09-10

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Clinical Senior QA Auditor

Kelly Services
Farmingdale, NY 11735

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