Job Overview The Quality Control Associate is responsible for transferring, executing, qualifying, and validating assays according to ICH guidelines and performing in-process, routine testing in support of material characterization and product commercialization activities.

Key Responsibilities:

• Perform routine testing including qPCR, ddPCR, SDS-PAGE, ELISA, and cell-based assays.
• Assist in the management of external vendors as it pertains to all aspects of testing GLP and GMP material, including transfer, qualification, validation, and monitoring of routine assays.
• Assist in the data review of results from CTOs in support of release, stability, and other in-process testing.
• Work in concert with and give guidance to assay development unit for optimization and qualification activities, including technical analysis and troubleshooting for the characterization of HSV and AAV in accordance with GLPs/GMPs.
• Support in-house Quality Control work through testing, data review, as well as the development and maintenance of reference materials, positive controls, and standards.
• Write and review study protocols, technical transfer protocol, test methods, technical reports, SOPs, test reports, Certificate of Tests, and any documents necessary to maintain or enhance the Company's Quality Control systems.
• Assist in technical transfer of Analytical methods to the Company, participate in assay Qualification and Validation.
• Compliance with the Company's Employee, Safety, and Quality manuals
• Compliance with FDA regulations regarding GLPs, GMPs, and GDPs
• Other duties as assigned.
• This job description is subject to change at any time. Educational Qualifications
• Bachelor's degree Additional Qualifications
• Level I - B.S. degree in a biological science or related field and 0-2 years of QC experience in a GLP/GMP environment, preferably in a biotechnology company
• Level

II - B.S

degree in a biological science or related field and at least 2-4 years of QC experience in a GLP/GMP environment, preferably in a biotechnology company

• Advanced proficiency with in vitro assays encompassing immunology, molecular biology, and/or cell biology such as ELISAs, PCR, and mammalian cell-based assays.
• Ability to evaluate assay methods according to ICH guidelines.
• Previous assay validation experience and knowledge of statistics is highly desirable.
• Highly motivated with the ability to work independently and in a team.
• Detail oriented with strong written and verbal communication skills.
• Working knowledge of

Microsoft Word, Excel, and PowerPoint Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Retirement plan Vision insurance Application Question(s): Will you now or in the future require employer sponsorship for employment visa status? Do you have a B.S degree in a biological science or related field and at least 2-4 years of QC experience in a GLP/GMP environment, preferably in a biotechnology company?

Work Location:

In person