Quality Control Associate I/II

Valid8 Financial, Inc.; Florida; On-site; USD 60,000 - 90,000; Full time

Job summary

Valid8 Financial, Inc. is seeking a Quality Control Associate to transfer, execute, qualify and validate assays per ICH guidelines and perform in-process, routine testing for material characterization and product commercialization.

The role reports to the Manager, Quality Control, and involves vendor coordination, data review for release and stability, assay development support, and ensuring compliance with FDA GLPs, GMPs and GDPs.

Qualifications

• B.S. degree in a biological science or related field.
• GLP/GMP environment experience.
• 0–2 or 2–4 years QC experience (Level I/II) in a biotech setting.
• Advanced proficiency with immunology, molecular biology, and/or cell biology assays.
• Ability to evaluate assay methods according to ICH guidelines.
• Experience with assay validation and statistics is desirable.
• Strong written and verbal communication; detail oriented.

Responsibilities

• Perform routine testing including qPCR, ddPCR, SDS-PAGE, ELISA, and cell-based assays.
• Assist in management of external vendors for GLP and GMP testing.
• Review results for release, stability, and in-process testing.
• Support assay development and qualification activities; troubleshoot HSV and AAV assays.
• Support in-house QC through testing, data review, and reference materials development.
• Write and review protocols, transfer protocols, test methods, reports, SOPs, and Certificates of Tests.
• Ensure compliance with FDA regulations for GLPs, GMPs and GDPs.
• Other duties as assigned.

Skills

qPCR

ddPCR

SDS-PAGE

ELISA

Cell-based assays

Statistics

MS Office

Education

B.S. in biological science

Tools

Excel

PowerPoint

Word

Job description

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.

Reporting Relationship

• The Quality Control Associate will report directly to the Manager, Quality Control, or designee.

Duties and Responsibilities

• Pe rform 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

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