- Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, throughout the lifecycle of an Audit
- Conduct all preparation meetings, assign tasks with other internal departments and gather necessary information on Sponsor confidentiality agreement documentation.
- Initiate planning process(es), e.g., project plans with deadlines and milestones, to administer an audit effectively and seamlessly
- -Ensure audits are performed to a high degree of client satisfaction
- -Build, develop, and maintain good working relationships with internal and external customer groups
- Determine most appropriate setting to host an audit, based upon sponsor audit requirements
- Actively support audit host throughout a sponsor audit onsite (where applicable)
- Support Non-Parexel-facility audits, e.g. supplier sites, internal audits at sponsor offices, as applicable
- Ensure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirements
- Summarize quality issues arising from sponsor audits and other related activities, as requested.
- Enter Sponsor audit information into the Parexel audit module of eQMS and provide follow up on outcomes, as needed.
- With First Time Quality - ensure that information is added and relayed effectively and correctly
- Create or contribute to Lessons Learned after any audit activity hosted, to ensure continuous quality improvement
- Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.
- Ability to review and offer feedback of associated standard operating procedures, from a QA perspective.
- Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel's international SOPs and compliance with GxP. Communicate to QA team and management, as applicable
- Promote compliance within the company and represent QA, as required
- Proactively re/review QA SOPs and be able to speak to their contents
- Develop and maintain network contacts with other Quality Assurance professionals
- Support regulatory inspections as needed
- Build, develop, and maintain good working relationships with internal and external customer groups.
- Work well in team environment.
- Travel time could be up to 20%.
- Educated to the degree level (BS, BA) or equivalent experience
-
Audit Specialist
1 week ago
PAREXEL Durham, United States Local OfficeDurham, NC (Hybrid Role) · The Sr Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections. Will exhibit a high degree of flexibility and initiative ...
-
Compliance Specialist-PB Audit
1 week ago
Duke University Durham, United StatesAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · About Duke Health's Patient Revenue Man ...
-
Compliance Specialist-PB Audit
1 week ago
Dukehealth Durham, United StatesAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · Is this the next step in your career F ...
-
Compliance Specialist-PB Audit
1 week ago
Duke University Durham, United StatesAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · About Duke Health's Patient Revenue Ma ...
-
Compliance Specialist-PB Audit
3 days ago
Duke University Durham, United States Full timeCompliance Specialist-PB Audit · Work Arrangement: · Requisition Number: 243469 · Regular or Temporary: Regular · Location: Durham, NC, US, 27710 · Personnel Area: PRMO · At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their ...
-
Quality assurance specialist
1 week ago
Cascade Innovations South Hill, United StatesQuality Assurance Specialist - QHSE Engineer (m/f/d) · We are 247TailorSteel West GmbH in Hilden , a subsidiary of 247TailorSteel BV based in the Netherlands. 247TailorSteel provides custom laser-cut and bent sheets and pipes. Currently, thousands of customers use the innovativ ...
-
IT System Administrator
1 week ago
Cascade Innovations East Duke, United StatesGet to know a reliable partner from our company for specialists and executives with East Duke. cademify opens the doors to exciting projects and creates new perspectives for your career. We are currently looking for an IT system administrator (m/f/d) for an attractive company in ...
-
Safety and Health Specialist
1 week ago
Duke University Durham, United StatesPrimary Purpose of Organizational Unit: The Occupational and Environmental Safety Office (OESO) provides the focus for the administration of all safety and environmental programs to Duke University, Duke University Medical Center, and Duke University Health System. OESO has the r ...
-
Electrical Quality Specialist
2 hours ago
Adams Electric Company Durham, United StatesReview electrical construction quality control practices to determine areas that require improvement. - Prepare written audit reports for management and the auditee to facilitate improvement. - Implements inspection, examination, and testing procedur Electrical, Specialist, Quali ...
-
Duke University Durham, United StatesPrimary Purpose of Organizational Unit: The Occupational and Environmental Safety Office (OESO) provides the focus for the administration of all safety programs to Duke University, Duke University Medical Center, and Duke University Health System. OESO has the responsibility for ...
-
Quality Laboratory Systems Specialist
2 days ago
MILLENNIUMSOFT Durham, United StatesPosition : Quality Laboratory Systems Specialist · Location : Research Triangle Park, NC · Duration : 12 Months · Total Hours/week : 40.00 · 1st Shift · Client: Medical Device Company · Job Category: Quality · Level Of Experience: Mid-Level · Employment Type: Contract on W2 (Ne ...
-
Safety and Health Specialist
1 week ago
Duke University Durham, United StatesAbout Duke University and Health System · Tracing its origins to 1838, Duke University has evolved into one of the world's leading institutions for education, research and patient care. Located in Durham, North Carolina, Duke is comprised of two major organizations: Duke Universi ...
-
Safety and Health Specialist
5 days ago
Duke University Durham, United StatesPrimary Purpose of Organizational Unit: The Occupational and Environmental Safety Office (OESO) provides the focus for the administration of all safety programs to Duke University, Duke University Medical Center, and Duke University Health System. OESO has the responsibility for ...
-
Audit & Accounts Senior
1 week ago
Clark Wood Durham, United StatesAudit & Accounts Senior with ref. CR-16088 | Clark Wood · Audit & Accounts Senior · Location · Durham · Sector: · Audit and Business Services ,Accounts & Audit · Contract Type: · Permanent · Salary: · Excellent Salary + Benefits · Contact: · Curtis Reid · Contact email: · ...
-
Senior Specialist, EHS&S
1 week ago
KBI Biopharma Durham, United StatesThe Senior Specialist has responsibility for the implementation of the Environmental, Health, Safety, and Sustainability (EHSS) program. This includes leadership to maintain EHSS compliance and continuous improvement. EHSS supports operations of biologic contract development and ...
-
Supply Chain Specialist
3 days ago
PEAK Technical Staffing USA Durham, United StatesSupply Chain SpecialistMonday -Friday 8:00am - 4:30pmResponsibilities: Manage and maintain accurate inventory levels for all products Conduct regular audits to ensure inventory accuracy and identify discrepancies Coordinate with suppliers and vendors to ensure timely delivery of ...
-
Direct Market Manager
4 days ago
ThinkTank LLC Durham, United StatesJob Description · Job DescriptionThinkTank Telecom, LLC is actively seeking a motivated and entrepreneurial Direct Market Manager to lead our expansion efforts in North Carolina - Durham. As the cornerstone of our mission to enhance connectivity, your role will focus on enrolling ...
-
Population Health Specialist- QuEST Team
1 week ago
Duke University Durham, United StatesAt Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together. · General Description · The Population He ...
-
EHS&S Specialist III
1 week ago
KBI Biopharma Durham, United StatesThe specialist has responsibility for the implementation of the environmental, health, safety, and sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manu ...
-
Safety Specialist
4 days ago
BMWC Constructors Durham, United StatesSafety Specialist II · Driven by Vision | Industrial-Strength Construction |Powered by Passion · What We Do · BMWC tackles the world's toughest and most daunting industrial construction challenges. Our work encompasses an array of industrial sectors, including aerospace, chemical ...
Audit Specialist - Durham, United States - PAREXEL
Description
When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Durham, NC (Hybrid Role)
The Sr Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections. Will exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and
projects, and possess the ability to handle confidential information.
End-to-End Facilitation of Sponsor Audits
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
