Job Title : Sr Quality Assurance Microbiology Specialist - Drug Product
Summary : Looking for a new opportunity with a leading Biotechnology company? My client is looking to add a Senior QA Microbiology Specialist - Drug Product to their team at this time. My client covers a multitude of disease areas including eye diseases, allergic/inflammatory diseases, cancer, cardiovascular/metabolic diseases, pain, hematologic diseases, infectious diseases and rare diseases. With 7 FDA approved medications on the market, there is a lot of opportunity for the 39 products currently in the pipeline to get commercialized to market. If this sounds like an organization you would be a great addition to, apply below!
The Sr QA Microbiology Specialist will be responsible for :
- Planning, coordinating and facilitating activities required to maintain sterility assurance throughout the development and commercialization of drug candidates.
- Reviewing microbial control related documents including SOPs, validation and qualification (IQ/OQ/PQ), study protocols and investigations.
- Working on GMP computer systems software to process change controls, technical documents, procedures, work instructions, protocols, etc.
- Review and assess the appropriateness of external manufacturing deviations and change notifications related to manufacturing processes to assure sterility assurance.
- Identifying continuous improvement opportunities.
The Sr QA Microbiology Specialist should have the following requirements :
- Bachelor's Degree in a microbiology or a life sciences field.
- At least 5 years of experience with microbiology and QA in a pharmaceutical setting.
- Knowledge, education, experience and training in microbiology, aseptic technique, environmental monitoring for controlled environments and microbiological testing such as bioburden and endotoxin.
- Ability to present data to sterility assurance and microbial control to leadership.
- Experience working with regulatory bodies such as FDA or EMA.
If this sounds like something you would be interested in, please apply!