Quality Control Analyst

DivIHN Integration Inc
Durham, NC

Title: Quality Control Analyst I

Duration: 12 Months

Location: Research Triangle Park, NC


Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.


Position Summary

The QC Analyst I, reporting to the Manager of Quality Control, will be responsible for serving as a performing routine GMP testing on analytical methods in the Quality Control laboratories.


Job Responsibilities

· Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques.

· Prepare solutions and maintain cell lines for various clinical programs

· Prepares laboratory solutions, maintains cell lines, and other day to day laboratory activities.

· Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data.

· Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records.

· Assist with management 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


Minimum Requirements

· Bachelor’s degree in biology or related field.