Quality Control Specialist
About The Position
The Quality Control Specialist is an entry level opportunity within the Quality Control organization at AskBio. This individual will perform routine GMP testing activities in a regulated gene therapy manufacturing environment. This position is responsible for analytical testing using established methods, preparing reagents and solutions, and supporting the maintenance of cell lines used across multiple clinical programs. The QC Specialist plays a critical role in ensuring data integrity, compliance and operational excellence within the QC laboratories. The Quality Control Specialist, reporting to the Manager of Quality Control, will be an office-based position in RTP, NC.
Requirements
- Bachelor’s degree in biology or related field
- Excellent verbal and written communication skills
- Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team
- Ability to handle multiple projects/teams simultaneously
- Ability to work independently in a fast-paced, highly interactive environment with minimal supervision
Nice To Haves
- Relevant work experience in cGMP regulated Quality Control laboratory
- Experience working for a pharmaceutical or biotech company
- GDP experience
- Experience with cell-based assays and PCR testing
- Experience working within a cGMP Quality Control LIMS system
Responsibilities
- Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques
- Prepare solutions and maintain cell lines for various clinical programs
- Prepare laboratory solutions, maintains cell lines, and other day to day laboratory activities
- Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data
- Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records
- Assist with management of analytical test method supplies and samples as needed
- Ensure lab areas are clean and organized, maintaining equipment and consumables
- Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments
- Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
- Participate in continuous improvement projects in the AD and QC labs
- Support revisions to work instructions, SOPs, forms, protocols, and reports
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
