Quality Control Analyst
About The Position
The Quality Control Analyst I will be responsible for performing routine GMP testing on analytical methods in the GMP Quality Control laboratories. This position is based on site in Durham, NC and reports to the Associate Director, Quality Control. This role is available for a secondment opportunity at AskBio, a company focused on advancing gene therapy. The duration of the secondment will be determined by leadership at both Bayer and AskBio, typically ranging from one to two years, based on business needs and mutual agreement. This secondment offers a chance to broaden experience, expand knowledge, and contribute to AskBio’s mission.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
