QC Analyst, Analytical Methods

Durham, NC

Position Overview:

The Contract QC Analyst, Analytical Methods will support GMP laboratory operations for in-process and release analytical methods across multiple programs. Responsibilities include testing of in-process samples, restocking control print copies, archiving GMP documentation, ensuring cleanliness of the lab, routine equipment maintenance, stocking of lab equipment and supplies, writing protocols or reports, supporting deviation write ups, and keeping track and progressing change controls and CAPAs. In addition, the QC contract analyst will also work to support implementation of control charting for analytical methods in the Quality Control laboratory located in Durham, North Carolina.

Responsibilities :

• Support routine in-process testing including CBC (Sysmex) and other bioassays as necessary.

• Maintain and operate analytical instrumentation including CBC (Sysmex), flow (MACSQuant 16) and other bioassays as per equipment and site SOPs.

• Support routine maintenance of the lab space including weekly/monthly maintenance activities.

• Support tracking, ordering and stocking of lab supplies.

• Independently draft and author GMP documents including protocols, reports, deviations, etc.

• Support writing and progressing of change controls, deviations, and implementation of CAPAs.

• Support implementation of control charting for analytical methods using JMP software.

• Must be able to work onsite daily.

Qualifications :

• Bachelor’s degree required, preferably in a life science discipline.

• 1-4 years relevant experience in a GMP space.

• 1 to 2 years hands on bioanalytical assay experience.

• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize.

• Ability to communicate effectively and clearly with peers, department management and cross-functional peers.

• Previous demonstrated technical writing skills required.

• Previous experience with JMP preferred but not required.