Position: Quality Assurance Manager at ADVENT ADVENT is a GMP-certified Contract Development and Manufacturing Organization,…
Job Position: Quality Control Associate ADVENT. IRBM.
IRBM Group has a GMP-certified Contract Development and Manufacturing Organization, ADVENT, located in Pomezia (Rome) within the IRBM campus and dedicated to production of clinical lots of recombinant adenovirus to support Phase I and Phase II clinical trials for vaccine and gene therapy applications. Our GMP is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the regulatory guidelines of both FDA and EMA. Over the years, the GMP team has built an outstanding track record in the successful production of clinical lots and is committed to the highest GMP quality standard.
We are looking for a highly motivated and team-oriented candidate for the position of Quality Control Associate, in Advent. She/he will join a fast-paced team and will support Quality Control activities with particular emphasis on the aspects related to Release of products and Stability Studies. The candidate will work cooperatively in cross-functional teams to ensure that the quality of the products are confirmed as indicated by regulatory requirements. As an IRBM employee, she/he will be committed to the highest operational standard and will contribute to the timely delivery of our services and products to our customers and their patients. A collaborative attitude is essential for this position.
- Develop, implement and perform QC tests including but not limited to qPCR, cell-based assays, Western Blot, PCR and Visual Inspection assays, following well established procedures.
- Testing and inspection of products at various stages of the production process.
- Statistical data compilation and evaluation to determine the quality and reliability of results.
- Write and follow standard operating procedures.
- Control of the manufacturing microbiological environment.
- Analyse starting materials, packaging materials and intermediate, bulk and finished products.
- Participate to the investigation for Deviations and Out Of Specifications.
- Handle Change Controls.
- Maintain high standards of laboratory safety and comply with all safety requirements according to Italian laws.
- Good communication skills, both verbal and written. Working knowledge of spoken and written English is mandatory.
- Outstanding organizational, record-keeping, and problem-solving skills.
- Proven experience in standard molecular and cell biology procedures, including tissue culture, protein and nucleic acid manipulation, experimental planning and data interpretation.
- Ability to work well independently and/or in a team to meet tight timelines.
- Working knowledge of computer programs such as MS Office and Adobe Acrobat.
- Knowledge of current GMP principles and previous experience in biochemistry would be considered a plus.
- BS degree in Biology, Biochemistry or related fields with 3-4+ years of relevant research experience. With MS degree, 1+ year experience is required.
- Previous experience in Biotech or Big-Pharma environment would be considered a plus.