Quality Control Analyst II

AskBio•Durham, NC

4h•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 pipeline of investigational therapeutics for various diseases and utilizes proprietary manufacturing processes and a wide array of genetic components. AskBio is committed to pioneering science, advancing transformative therapeutics, and fostering employee potential. The Quality Control Analyst II will perform routine testing in GMP Quality Control laboratories, support quality events, and contribute to continuous improvement initiatives. This role is based in Durham, NC.

Requirements

Bachelor’s degree in a scientific field
2+ years’ experience in a cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field
Ability to handle multiple projects/teams simultaneously
Ability to work independently in a fast-paced, highly interactive environment with minimal supervision
Excellent verbal and written communication skills
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team
Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams

Nice To Haves

Experience with cell-based assays, PCR testing, and/or HPLC testing
Experience working within a cGMP Quality Control LIMS system
Experience working with deviations, CAPAs, change controls, and/or OOS quality events

Responsibilities

Perform routine analytical testing including cell-based potency assays, ddPCR, qPCR, ELISAs, and limit tests using HPLC techniques.
Prepare laboratory solutions, maintain cell lines, and manage inventory of materials.
Participate in tracking and trending activities for analytical data.
Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner.
Support activities for qualification of laboratory equipment and analytical methods.
Serve as a trainer for applicable methods for new analysts.
Support Quality Control initiatives such as streamlining documentation and creating/updating SOPs.
Collaborate with Analytical Development, Quality Control, Quality Assurance, Production, and other relevant departments.
Adhere strictly to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
Participate in continuous improvement projects in the AD and QC labs.
Revise processes, work instructions, SOPs, forms, protocols, and reports.
Own deviations, CAPAs, change controls, and OOS investigations, driving them to closure in accordance with internal timelines and external partners.