Quality Control Specialist

Job Description

Mission

The Quality Control Specialist 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 Specialist will report directly to the Manager, Quality Control or designee

Duties and 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 AGTC’s Quality Control systems
  • Assist in technical transfer of Analytical methods to AGTC, participate in assay Qualification and Validation
  • Compliance with AGTC’s Employee, Safety, and Quality manuals
  • Compliance with FDA regulations regarding GLPs, GMPs, and GDPs
  • Other job duties as assigned
  • This job description is subject to change at any time

Educational Qualifications

  • Bachelor’s degree

Additional Qualifications

  • Quality Control Specialist I - B.S. degree in a biological science or related field.
  • Quality Control Specialist II - B.S degree in a biological science or related field and at least two (2) 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

Physical Requirements

  • Physical demands: 

☐ sedentary (< 10 lbs.)

☒ light work (< 20 lbs.)

☐ medium work (< 50 lbs.)

☐ heavy work (< 100 lbs.)

☐ very heavy work (> 100 bs.)

 

  • Physical activity: 

☒repetitive motion

☐ balancing

☒stooping

☒lifting

☐climbing

☒kneeling/crouching

☐crawling

☒reaching

☒standing

 

☒ typing/grasping

☒walking

☒pushing/pulling

☒hearing

 

  • Visual acuity: reading, writing, preparing/analyzing data,  
  • Working conditions: indoor office environment and lab area

 Supervisor Responsibilities

  • This position does not have supervisory responsibilities
Contact Information