Quality Assurance Validation Associate in Totowa, New Jersey at New Cibo Vita LLC

The QA Validation Associate supports the development, execution, and documentation of
validation protocols to ensure that all equipment, manufacturing processes, cleaning procedures,
and systems consistently meet quality and regulatory standards. Working under the guidance of
the QA Validation Lead, this role is essential in maintaining Good Manufacturing Practices
(GMP) and ensuring our Totowa facilities remain audit-ready and compliant with food safety
regulations.
Key Responsibilities:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
Working Conditions
Environment: On-site manufacturing role across multiple Totowa facilities.
Physical: Requires standing for extended periods during trials, wearing required PPE,
and adhering to strict food safety protocols.
Schedule: Primarily day shift, with occasional flexibility required for off-shift or
weekend validation trials to minimize production downtime.