Quality Control Senior Specialist (Contract) 24645
Job Description:
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.
Minimum qualifications:
Knowledge and Skills:
- Demonstrated knowledge and skills in multiple analytical techniques such as flow cytometry, cell-based assays, qPCR, and ELISA.
- Strong technical communication and technical writing skills.
- Proficient in MS Office, and Statistical analysis software. Familiarity with Project management tools is a plus.
- Ability to handle multiple priorities and deliverables in a timely manner and attention to detail.
- Ability to work independently and in a team environment.
- Self-motivated individual with a can-do attitude and problem-solving skills.
Education and Experience:
- 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.
Pay Range:
$55-$65/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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No C2C or Third-Party Vendors