Associate Quality Control - NS

Job title:

Associate Quality Control Duration:

11+ Months (Possibility of Extension)

Location:

27540,

Holly Spring, NC Working Schedule:

2pm-10pm Sunday - Wednesday or Wednesday-Saturday First few weeks of the training will be on Dayshift schedule

Description:

Execute QC activities, working with the day and night shift managers, including sample receipt, prioritization, and accurate entry into LIMS. Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required. Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements. Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership. Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS). Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.

Basic Qualifications:

High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree

Preferred Qualifications:

Preferred - Bachelor's degree in a scientific discipline or equivalent experience, entry level will be considered. Experience working in a GMP-regulated environment and ability to work independently. Top 3

Must Have Skill Sets:

Experience working in a GMP-regulated environment Ability to work independently Laboratory or aseptic knowledge Day to

Day Responsibilities:

Execute QC activities, working with the day and night shift managers, including sample receipt, prioritization, and accurate entry into LIMS. Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required. Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements. Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership. Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS). Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.

Red Flags:

Frequently moving jobs Low energy or motivation Unwilling to take on new challenges