Vendor/Audit Specialist

Salary:

Join our growing team at WEP Clinical, a specialist services company dedicated to fostering innovation, collaboration, and patient-centric excellence. We are on the forefront of cutting-edge research, and as we expand, we're seeking ambitious individuals who are passionate about making a real impact in patient treatment. If you're a team player ready to embark on a journey of professional growth within a rapidly evolving organization, apply now and be a part of our mission to redefine possibilities in clinical research!

 

 

Role Objectives

The WEP Clinical Quality Assurance Vendor/Audit Specialist is responsible for performing and assisting with all aspects of vendor and audit management as it relates to all WEP Clinical Quality systems and related processes, ensuring GxP compliance, as applicable.

The Ideal Candidate:

• Adaptable/Flexible
• Organized
• Strong Communicator
• Detail-Orientated

Principal Duties and Responsibilities

• Responsible for independently planning, leading, conducting and reporting of internal and external audits in accordance with the approved schedule and timelines.
• Responsible for audit report production and approval of CAPA plans in accordance with internal timelines.
• Conduct peer review of audit reports for both internal and external auditors.
• Assist with maintaining a compliant Quality Management System (QMS).
• Responsible for qualification and maintenance of vendors within the QMS.
• Responsible for ensuring GxP compliance and best practice within all regulated activities.
• Ensure that WEP Clinical operations do not compromise patient safety and/or the quality of supplied drug products.
• Contribute to all quality related event documentation (deviations, investigations, CAPAs, etc.) to ensure a timely closeout of all associated actions.
• Maintain adequate records of all quality and operational activities at WEP.

  Qualifications:

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 3-4 years of GxP auditing experience (to include GDP, GMP, and GCP) in the pharmaceutical or life sciences industry.
• Auditor certification preferred
• Basic computer skills required, with the ability to work within all Microsoft Office Suite systems (Word, Excel, and PowerPoint).
• Strong organizational skills
• Knowledge of GxP requirements (to include GDP, GMP, and GCP) required.
• Excellent written and oral communication skills
  

What We Offer:

• Medical, dental, and vision insurance, HSA, FSA
• Group short-term and voluntary long-term disability insurance
• Group life insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick, and volunteer time
• Paid maternity & paternity leave,
• Education assistance

✨ What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives in place to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Expanded Access Programs (EAPs)

Open Label Extension Studies (OLE)

Named Patient Programs (NPPs)

Clinical Trial Supplies (Comparator & Ancillaries)

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Hospital Supply of Unlicensed Medicines

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

remote work