Quality Control Analyst II

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

2d•Onsite

About The Position

This role is a secondment opportunity at AskBio, a company focused on advancing gene therapy. The Quality Control Analyst II will perform routine testing in GMP Quality Control laboratories and support quality events. This position is based on site in Durham, NC and reports to the Associate Director, Quality Control. The secondment duration 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 role offers a chance to broaden experience, expand knowledge, and contribute to AskBio’s mission of transforming lives through gene therapy.

Requirements

Bachelor’s degree in a scientific field
2+ years’ experience of in 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 but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques.
Prepares laboratory solutions, maintains cell lines, maintain inventory of materials, and other day to day laboratory activities.
Participates in tracking and trending activities for analytical data.
Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner.
Supports activities for qualification of laboratory equipment and analytical methods.
Serve as a trainer for applicable methods for new analysts.
Support Quality Control initiatives as needed, including but not limited to streamlining documentation, creating/updating SOPs, etc.
Work closely with Analytical Development, Quality Control, Quality Assurance, Production 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.
Revises 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.