Wugen Inc. is seeking exceptional and highly motivated candidates to join our growing CMC team to be based in St. Louis, MO or San Diego, CA. This candidate will be responsible for helping to maintain Wugen Quality Systems as well as interacting with internal and external parties to provide Quality support.
- Champion the integration of core Quality Systems for Wugen including documentation, investigations, CAPA, training and change control.
- Perform Quality Assurance review and approval of documents, records, specifications, and investigations.
- Collaborate with functional teams to provide Quality guidance and assistance with controlled documents, training requirements and deviation resolution.
- Provide routine Quality Systems support to Wugen teams including change control, management of records and data, and tracking of continuous improvement.
- Apply critical thinking and problem-solving skills to identify potential compliance issues and escalate when appropriate.
- Assist in the development of Quality Agreements and Quality metrics.
- BS/MS degree in science with 2+ years of work experience.
- Experience working in the Pharmaceutical industry.
- Applied knowledge of Quality/Compliance and GMP and GLP requirements.
- Knowledge of biologics research, manufacturing and/or testing is preferred.
- Self-motivated with ability to work independently and operate effectively within 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.