Overview
Quality Control Senior Specialist (Contract) Jobs in Boston, MA at BioPharma Consulting JAD Group
Title: Quality Control Senior Specialist (Contract)
Company: BioPharma Consulting JAD Group
Location: Boston, MA
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:
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
Skills:
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
Requirements
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
