What are the responsibilities and job description for the Quality Control Analyst I position at DivIHN Integration Inc.?
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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The purpose of the Analyst I, Quality Control (Non-Clinical) is to perform analytical testing to support the release of Non-Clinical grade rAAV vector lots manufactured in various departments (including, Pre-Clinical Manufacturing, Process Development, MSAT) and external partners. The rAAV vectors tested/characterized by the team will support capsid technology development, intellectual property portfolio, and internal progression of early-stage gene therapy programs.
Job Responsibilities:
- Perform routine and complex execution of molecular biology and biochemistry analytical methods such as qPCR, d/ddPCR, ELISA, HPLC, endotoxin etc.
- Organize and perform data analysis at completion of each test method, peer review data.
- Assist with evaluation of analytical results and final reports.
- Follow SOPs and document analytical test method procedures.
- Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records.
- Contribute to technical discussions and investigations.
- Assist with management of raw materials, analytical test method supplies, and samples as needed.
- Ensure lab areas are clean, organized and equipment, supplies and raw materials are available for use.
Preferred Education, Experience and Skills:
- Relevant work experience (0-3 years) in areas such as, analytical testing, development, and technology transfer; in rAAV/gene therapy, recombinant protein/biomolecules, and/or other advanced therapeutic modalities.
- Experience with electronic laboratory notebooks is a plus.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.