Senior Quality Control Data Reviewer

Description:

Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot)

Review QC Data

Help run method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents

Review QC data released from QC testing

Trend data for qualified materials, release products, and stability products.

Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control

Author and review test methods, development reports, study protocols, and validation reports

Skills:Quality control, Agarose Gel Electrophoresis, Elisa, PCR, QC Data review, SDS page, Spectrophotometry Assay, Qc testing, AAV, Gmp, ddpcr, bacterial plasmid, Microbiology, cell culture, Data review, validation transfer, change control, Quality assurance, molecular biology, cell biology, virologyAdditional Skills & Qualifications:

BS. or M.S. degree in molecular biology, cell biology or virology with at least 5-8 years relevant experience

Experience with GMP

cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays

Knowledge of compendial (USP, ICH, EP) guidance

Use of developing, validating, and deploying molecular biology test methods

Experience Level:Expert LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.