Associate Quality Assurance

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., 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.

• 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., * 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, * 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.