General Information

Location: Princeton, NJ

Organization: WCG

Job Type: Full Time - Regular

Description and Requirements

JOB SUMMARY: The Associate, Operations QA & Compliance is responsible for assisting and supporting the Compliance team with respect to establishing and maintaining quality assurance standards and measures across WCG services organization and ensuing such standards comply with regulatory requirements and best practice. This position is responsible for working alongside the senior compliance team and WCG employees to ensure the CTS organization remains compliant with WCG’s Quality Management System and business processes.

VACCINATION:
To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

EDUCATION REQUIREMENTS:
  • Bachelor’s degree or local equivalent in medicine, science, technology, or equivalent degree/experience.

QUALIFICATIONS/EXPERIENCE:
  • Two to four (2-4) years’ experience in a quality/regulatory compliance position with evidence of increasing responsibility.
  • Knowledge of current regulatory and GCP guidelines as they apply to clinical trials.
  • Familiarity and experience with audit preparation as well as assisting/facilitating customer and/or process audits.
  • Significant technical writing skills.
  • Experience in training others on standards and ensuring compliance with employee education.
  • Effective communication (written and oral) skills, organization, and interpersonal skills as well as the ability to interact with WCG staff and clients as needed.
  • Knowledge and understanding of drug development and the clinical trial process.
  • Ability to problem solve and engage in the resolution of conflicts.
  • Ability to work efficiently and independently.
  • Proficiency with a learning management system as well as MS Word, MS Excel, and MS PowerPoint.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
  • Support the continued development, maintenance, and enforcement of the CTS Quality Management System.
  • ­Assist senior compliance team members to establish and enforce CTS quality department standards.
  • ­Assist and support efforts to implement of CTS quality goals, objectives, and process improvements.
  • ­Train WCG staff on CTS quality department standards and best practices.
  • Lead assigned work and provide quality oversight over the implementation, and/or development, of WCG businesses.
  • Assist in the development, implementation and release of controlled documents to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, GDPR, and HIPAA.
  • ­Complete all internal training assignments in a timely manner.
  • Support the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF).
  • ­Ensure proper investigation of such events is performed, and documentation maintained.
  • Conduct internal audits to ensure that internal standards and staff performance follow applicable WCG processes, regulatory agency regulation and guidance.
  • ­Execute internal audits/periodic review of WCG policies, processes and procedures.
  • ­ Identify compliance gaps and provide support and suggestions for remediation.
  • ­ Draft audit reports as applicable.
  • Conduct external vendor qualification audits to ensure vendor standards and performance follow applicable
  • WCG process, regulatory agency regulations and guidance.
  • Develop vendor audit plans, reports, collection of responses, and follow up.
  • Support the hosting of external audits and assist inspections including internal audit preparation activities, audit activities, review of audit report, collection of responses, and follow-up on findings resolution.
  • Maintain current knowledge with respect to quality legislation and regulatory compliance best practice.
  • Provide training and guidance to staff regarding compliance and interpretation of regulations.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

TRAVEL REQUIREMENTS:  10% - 20%

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