Quality Assurance Validation Associate

Key Responsibilities

• Protocol Support & Development - Assist in authoring and updating validation protocols for equipment, production processes, and cleaning cycles. Help define acceptance criteria and sampling plans based on technical inputs from Production and Engineering. Ensure all draft protocols align with internal SOPs and regulatory expectations before execution.
• Execution of Validation Trials - Coordinate and perform on-floor validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Record raw data, observations, and any deviations in real-time during trials to ensure documentation integrity. Monitor critical control parameters to verify that equipment is operating within validated limits.
• Data Analysis & Reporting - Compile and organize data from completed trials to assist in the preparation of final validation reports. Identify and escalate any "out of specification" results or failed criteria to the Validation Lead. Maintain the site validation master file and ensure all records are filed according to document control standards.
• Compliance & Audit Readiness - Support the facility’s "Audit 365" posture by ensuring all validation paperwork is complete and accessible for FDA, SQF, or third-party inspections. Participate in internal quality audits to verify that validated states are being maintained on the production floor. Stay updated on current food safety trends and GMP requirements related to equipment and process qualification.
• Continuous Improvement - Identify opportunities to streamline validation sampling or data collection to improve efficiency. Assist in training production and sanitation personnel on new validated procedures or updated SOPs. Support the QA team in drafting or revising SOPs related to equipment maintenance and calibration.

Qualifications

• Education: Associate degree in a technical field (Food Science, Engineering, Biology) or a bachelor’s degree in progress.
• Experience: 1–3 years of experience in a quality or manufacturing role; experience in a regulated environment (Food, Pharma, or MedTech) is preferred.
• Technical Skills: Basic understanding of GMP, HACCP, and the IQ/OQ/PQ framework.
• Communication: Strong technical writing skills and the ability to communicate clearly with cross-functional teams.
• Software: Proficiency in Microsoft Office (Excel/Word); familiarity with Quality Management Systems (QMS) is a plus.