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 as well as interacting with internal and external parties to provide Quality guidance and support.
- Perform Quality Assurance review and approval of GMP/GCP documents, including specifications, labels, reports, and protocols.
- Provide Quality review of executed batch records, investigations, and test results for the disposition of drug product.
- Manage and maintain 3rd party vendors from a Quality perspective including qualification, issue resolution, risk assessments, and Quality Agreements.
- Collaborate with functional teams to provide Quality guidance and assistance with deviation resolution, CAPAs, data integrity, and GMP/GCP best practices.
- Apply critical thinking and problem-solving skills to identify potential compliance issues and offer solutions.
- Assist in the development of SOPs and Work Instructions.
- BS/MS degree in science with 2-4+ years of pharmaceutical work experience.
- Applied knowledge of Quality/Compliance and GMP, GLP, GCP requirements.
- Knowledge/experience in biopharmaceutical research, manufacturing and/or testing is preferred.
- Knowledge/experience in Clinical QA, with biologics/cell therapy experience a plus.
- Knowledge/experience with vendor/supplier audits and auditing a plus.
- 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.