Quality Control Analyst II

AskBio•Durham, NC

4h•Onsite

About The Position

Opportunity for Secondment to AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. The Quality Control Analyst II will be responsible for performing routine testing on analytical methods in the GMP Quality Control laboratories and supporting quality events. This position is based on site in Durham, NC and reports to the Associate Director, Quality Control.

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.