Quality Control Analyst
Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC
•Onsite
About The Position
AskBio Inc., a subsidiary of Bayer AG, is a gene therapy company focused on developing life-saving medicines. The company has a clinical-stage pipeline for various disease indications and utilizes proprietary technologies like Pro10™ for manufacturing. AskBio is committed to pioneering science, advancing transformative therapeutics, and fostering employee potential. The Quality Control Analyst I role is based in Durham, NC, and involves performing routine GMP testing in Quality Control laboratories.
Requirements
- Bachelor’s degree in biology or related field
- Excellent verbal and written communication skills
- Ability to handle multiple projects/teams simultaneously based on general instruction
- Ability to work independently in a fast-paced, highly interactive environment
- Ability to build open and collaborative relationships and work effectively as a member of the QC department
Nice To Haves
- Relevant work experience in cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field
- GDP experience preferred
- Experience with cell-based assays and PCR testing is preferred
- Experience working within a cGMP Quality Control LIMS system preferred
Responsibilities
- Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, quantitative or limits testing using HPLC techniques
- Prepares laboratory solutions, maintains cell lines, maintain inventory of materials, and other day to day laboratory activities
- Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner
- 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, organized, maintain equipment and consumables
- Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments
- Strictly adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
- Participates 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
