What are the responsibilities and job description for the Quality Control Senior Specialist (Contract) position at BioPharma Consulting JAD Group?
The Senior Specialist, Quality Control provides technical support for Type 1 Diabetes (T1D) Cell Quality Control (QC). This includes execution and support of analytical method transfers, qualification, validation and training to both internal QC and to external contract development and manufacturing organizations (CDMO). This position reports to the Quality Control Senior Manager, VCGT
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
Qualifications:
Knowledge and Skills:
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Execute and support analytical method technical transfer, qualification, validation both internally and externally including, flow cytometry, qPCR, cell count and viability, ELISA, and cell-based potency assay, etc
- Participate in delivery of appropriate documentation to support transfer, such as SOPs, qualification/validation protocols and reports, and training of QC analysts
- Support QC in investigation of assay related issues, Out-of-Specification, change controls, and deviations/CAPAs
- Assist in qualification of controls, standards, and critical reagents
- Assist in monitoring assay performance and driving continuous improvement
- Strong technical communication and technical writing skills
- Proficient in MS Office, and Statistical analysis software. Familiarity with Project management tools
- Ability to handle multiple priorities and deliverables in a timely manner and attention to detail
- Ability to work independently and in a team environment
Qualifications:
Knowledge and Skills:
- Demonstrated knowledge and skills in multiple analytical techniques such as flow cytometry, cell-based assays, qPCR, and ELISA
- Bachelor's or Master's degree in biology, biochemistry, microbiology, or other related science is required
- At least 2-5 years of experience in the pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
- Experience in analytical Quality Control, method development, method transfer/qualification/validation, or technical support is required, preferably in cell-based therapy
