Associate Quality Assurance

Job Title:

Associate Quality Assurance Duration:

6 Months( PE)

Location:

Holly Springs, NC Note:

Fully Onsite Dayshift, 8:00 AM or earlier start time

Ideal Candidate:

Local Candidates - Not open to relocation candidates 4-5 years of industry experience QA and GMP experience Raman Technology experience Onsite 5 days a week. Job Details We are seeking a Quality Assurance Senior Associate to support the client North Carolina (ANC) Quality Assurance team. This role provides dual-function support across Incoming Quality Assurance (IQA) and Warehouse QA floor operations, ensuring raw materials and warehouse activities comply with cGMP, internal procedures, and quality standards. The position includes real-time QA oversight on the warehouse floor, execution of inspection, sampling, and Raman spectroscopy testing for IQA, and serving as a primary QA contact for event triage and deviation management. Basic Qualifications High School/GED + 2 years of work experience, OR Associate's degree and 6 months of work experience, OR Bachelor's degree Top 3 Must-Have Skill Sets QA experience Knowledge of and hands-on experience handling deviations GMP warehouse knowledge Nice to Have Warehouse experience Day-to-Day Responsibilities Incoming Quality Assurance (IQA) - Inspection, Sampling, and Testing Perform inspections of raw materials (e.g., biobags, tubing, filters, components) to verify compliance with specifications and master inspection characteristics. Execute sampling of media, chemicals, and raw materials in accordance with approved procedures. Perform Raman spectroscopy testing using TruScan equipment to verify material identity. Ensure all inspection, sampling, and testing results are complete, accurate, and documented in compliance with cGMP and GDP (ALCOA) requirements. Evaluate material attributes (e.g., color, appearance, integrity) against defined acceptance criteria. Accurately document results in applicable systems and ensure traceability and data integrity. Assess and escalate characteristics that may impact product quality in accordance with procedures. Warehouse QA Floor Support (Real-Time Oversight) Provide on-the-floor QA presence to support warehouse operations (receiving, sampling, dispensing, shipping). Perform real-time triage of quality events, discrepancies, and process deviations. Determine immediate containment actions and provide compliant, risk-based guidance to operations. Ensure adherence to GMP requirements, SOPs, and

GDP/ALCOA

documentation standards. Act as the primary QA point of contact for operational questions and quality-related decision-making. Deviation, CAPA, and Quality Systems Support Serve as QA contact for deviations, including initiation, classification, and documentation. Ensure timely escalation of critical quality issues to QA leadership. Inspection Readiness and Continuous Improvement Participate in inspections, walkthroughs, and audit readiness activities. Ensure facilities, equipment, materials, and processes comply with cGMP and safety requirements. Possible Extension Yes Red Flags No experience working in a GMP environment. Non-local candidates. Unable to work with chemicals. Unable to stand for the majority of the shift. Unable to occasionally lift up to 50 lbs. Interview Process Video interview with hiring managers.