QA Specialist - Clinical Manufacturing
Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
- Member of a dynamic and scientifically driven team dedicated to the development and optimization of robust clinical manufacturing processes for drug products.
- Leverage basic understanding of clinical manufacturing processes to conduct post-execution GMP compliance review of the manufacturing batch record and all other required supporting/related documents.
- With the appropriate level of supervision, responsible for support of timely closure of investigations and change management records to ensure on-time compliant supply of clinical drug product for development/commercial portfolio.
- Compile and maintain the clinical supply batchdata base for analysis in support of process development/optimization activities.
- Assume departmental responsibilities for assigned projects.
- Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
- Degree in Chemical Engineering, Pharmaceutics, Chemistry or Material Science, or a relevant scientific discipline
- M.S. and 2+ years of relevant experience
- B.S. and 4+ years of relevant experience
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
- Strong verbal communication and technical writing skills are essential; able to communicate results and issues effectively.
- Ability to work in a team environment with engineers, scientists, and quality assurance professionals.
- Knowledge and demonstrated application of cGMPs during pharmaceutical development and commercial manufacturing.
- Detail-oriented with a high degree of focus
- Strong Computer skills with knowledge of MS Office program suite, with an emphasis in MS Word, MS Excel, MS PowerPoint.