Senior Auditor, Quality & Compliance Consulting (United States)
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POST DATE 8/30/2016
END DATE 12/2/2016
New Hope, PA
JOB DESCRIPTIONDo you want to be a part of a global top 10 CRO* INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we ve continued to improve what we do.
Here at INC Research we have experience working functionally and cross-functionally within a wide range of mid- and top-tier biopharmaceutical companies. We work with a variety of functions, including Clinical Development, Clinical Operations, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Affairs.
We are currently looking to strengthen our Quality Assurance team in North America and are seeking a Senior Auditor to join our Quality and Compliance Consulting team.
A brief summary of duties you will be involved in as a Senior Auditor, Computer Systems Quality Assurance:
Conducts audits of on-going projects and stand-alone Quality Assurance (QA) consulting activities.
1. Schedules, conducts and documents assigned audits of the projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to:
* Investigator Sites
* Trial Master and Project Management Files
* Data Management Activities and Files
* Safety Reporting
* Final Study Reports
2. Leads for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
3. Conducts audit debriefs with project teams and/or sponsor as required.
4. Writes and issues audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
5. Follow up as appropriate to obtain audit response. Reviews responses to audit findings for appropriateness and completeness.
6. Maintains accurate and timely documentation of QA auditing activities.
7. Serves as a trainer and mentor to newly hired QA Auditors.
8. Serves as Global Lead Auditor on projects as assigned.
9. Maintains subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
10. Participates in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.
To succeed in this role you will need the following skills/experience:
BA/BS degree in the science/health care field or equivalent combined education and experience. Extensive experience in clinical quality assurance auditing and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc). Strong knowledge of all applicable Good Clinical Practice regulations and guidelines. Knowledge of medical terminology preferred. Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Strong organizational, presentation, documentation and interpersonal skills with diverse cultures. Ability to negotiate and provide constructive feedback. Must be able to work as part of a team as well as independently. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
The Document Auditors are responsible for conducting QA audits of regulatory submission documents such as clinical study report, summary of clinical safety, summary of clinical efficacy, clinical overview, product label and rapid responses, etc, working with the teams to review/discuss audit responses and prepare and issue audit reports. The Document Auditors will consider scientific content, data, study objectives and consistency of conclusions within documents and across submission documents to evaluate quality and conformance. The Document Auditors will prepare daily audit comment logs to communicate potential observations on a daily basis to the Customer study team. The Document Auditors will review responses from the team to potential observations and prepare an audit report per SOPs and procedures.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don t worry if you ve got the passion part, we ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We ve got an attitude at INC: Can do, I own it. Absolutely everyone has ownership of what they do here. And because we re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
We were ranked Top CRO to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
INC Research is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you d like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf . This link will take you to the Equal Employment Opportunity is the Law Poster, which describes protection available under Federal law from discrimination. We are a drug-free workplace. In the United States, INC Research voluntarily participates in the federal E-Verify work authorization program.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to email@example.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.