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Quality Control Senior Associate

Spectraforce Technologies
United States, North Carolina, Holly Springs
Apr 02, 2026
Job Title: Quality Control (QC) Analyst - 2nd Shift Location: Holly Springs, NC (Fully Onsite) Shift: 2nd Shift - 2:00 PM to 10:00 PM Work Schedule: Sunday-Wednesday OR Wednesday-Saturday Training: First few weeks on Day Shift Duration : 1 year and 3 days Position Overview We are seeking a detail-oriented QC Analyst with experience in GMP-regulated environments to support second shift laboratory operations. The ideal candidate will have strong experience in quality systems, analytical testing, and documentation, along with the ability to work independently in a fast-paced setting. Key Responsibilities Execute QC second shift activities including: Sample receipt, prioritization, and LIMS entry Act as point of contact for Manufacturing during night shift: Support production schedules Resolve issues and escalate risks Perform routine and complex analytical testing: Chemistry, bioassay, and/or microbiology STAT testing as required Ensure accurate and compliant documentation: GDP, GMP, and 21 CFR Part 11 standards Support investigations: Deviations and OOS (Out of Specification) results Utilize electronic systems: LIMS Biovia (LES, ELN, CIMS/CISPro) Veeva Vault (QualityDocs, QMS) Collaborate cross-functionally to meet timelines Contribute to continuous improvement initiatives Basic Qualifications High School Diploma/GED + 2 years of experience Associate's Degree + 6 months of experience Bachelor's Degree Preferred Qualifications 3+ years of experience in GMP-regulated lab or manufacturing environment Experience writing and owning: Deviations CAPAs Hands-on experience with Veeva Quality system Strong understanding of QC laboratory processes Excellent written and verbal communication skills Ability to work independently with minimal supervision Top 3 Must-Have Skills Strong written and verbal communication Experience working in a GMP laboratory Ability to work independently Day-to-Day Responsibilities Manage QC shift activities and coordinate with team leads Perform analytical testing and document results Support manufacturing operations during shift Handle deviations, investigations, and risk communication Maintain compliance with regulatory standards Use quality systems and electronic tools effectively