Job Description
Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing QA team to be based in St. Louis, MO or San Diego, CA. This candidate will be responsible for helping to maintain Wugen quality systems through electronic document management.
The Quality Assurance Associate Scientist/Scientist is responsible for assisting with the Veeva Quality Document Management System and associated programs to achieve and maintain compliance with applicable regulations and to support the training program. The successful candidate has excellent communication skills and a commitment to teamwork. A candidate with a strong working knowledge of Veeva is preferred.
Primary Responsibilities
- Perform Quality Assurance review and approval of Clinical documents including protocols, Informed Consents, Investigator Brochures, Trial Master Files, clinical labels.
- Provide input to clinical functions to ensure that clinical trial activities are conducted by CROs in compliance with GCP guidelines, applicable legislation, and internal requirements.
- Assist with the management and maintenance of the GCP vendor qualification and management program.
- Participate in remote, domestic and international GCP routine and ‘for cause’ audits for clinical investigative sites, vendors, and trial master files (TMFs).
- Collaborate with functional teams to provide quality guidance and assistance with development of documents and processes using risk management principles.
- Assist with the develop of Quality Systems to support Wugen sponsored Clinical Trials including complaints, management of documents, records and data, and tracking of protocol deviations/corrective and preventative actions and their resolution.
- Champion the integration of core Clinical Quality Systems for Wugen including documentation, investigations, CAPA, and change control.
- Apply critical thinking and problem-solving skills to identify potential compliance issues and offer solutions.
- Assist with the management of the GCP training program and other required clinical quality assurance based trainings.
- Participate in preparations for regulatory inspections/mock regulatory inspections.
- Assist with the development, implementation and management of quality oversight plans, tools, and templates.
Preferred Qualifications:
- BS/MS degree in science with 3+ years of pharmaceutical work experience, with at least 12 months GCP QA experience.
- Applied knowledge of Quality/Compliance and GCP, GLP, and/or GMP requirements.
- Knowledge/experience in Clinical QA, with oncology experience a plus.
- Self-motivated with ability to work independently and as part of a team in an entrepreneurial fast-paced, collaborative work environment.
- Detail oriented with strong organizational and communication skills.
- Strong knowledge in standard software including Word, Excel, and PowerPoint.
