Quality - QA Systems & Compliance Associate

QA Systems & Compliance Associate

Totowa, New Jersey (Onsite)

Quality Assurance – QA Systems & Compliance

QA Systems & Compliance Lead

Full-Time / Exempt

$50,000 – $60,000 per year

Englewood Lab is seeking a QA Systems & Compliance Associate to provide broad quality systems, compliance, and quality engineering support across the site’s Quality Management System. The position supports internal, external, customer, supplier, and regulatory audits; supplier qualification and supplier quality activities; quality investigations and CAPA; validation and qualification; data integrity; calibration/metrology; and continuous improvement initiatives. The role works cross-functionally with QA/QC, Manufacturing, R&D, Process Engineering, Warehouse, Purchasing, Regulatory Affairs, external laboratories, suppliers, auditors, and customer quality contacts.

• Plan, schedule, and conduct internal quality system and process audits against cGMP, ISO, customer, and internal requirements
• Prepare audit plans, checklists, and reports, document objective evidence, and classify findings based on risk
• Track audit findings and corrective actions through closure and verify implementation and effectiveness
• Host and support customer audits, certification/registrar audits, and regulatory inspections, including FDA inspections
• Coordinate responses to external and customer audit observations and track related CAPAs through closure
• Support supplier and contract laboratory audits as part of qualification and requalification activities
• Maintain audit schedules, documentation, metrics, findings, and trends
• Support ongoing site audit and inspection readiness

• Support validation and qualification activities, including IQ/OQ/PQ, process validation, cleaning validation, and test method validation
• Draft and execute validation protocols and summarize results
• Apply statistical methods such as Cpk/Ppk, trending, and sampling analysis to monitor process performance
• Support risk-management activities, including FMEA, risk assessments, and control plans
• Support oversight of the calibration and metrology program and escalate out-of-tolerance conditions
• Apply quality engineering tools to improve product quality, process performance, and compliance

• Support the supplier qualification and requalification program and maintain qualification criteria, records, and the Approved Supplier List (ASL)
• Qualify suppliers, contract manufacturers, and laboratories through risk assessments, documentation reviews, and onsite or remote audits
• Monitor supplier performance through quality metrics, scorecards, defect trends, complaints, and NCRs
• Issue and manage Supplier Corrective Action Requests (SCARs) and track corrective actions and effectiveness
• Support and maintain quality agreements with suppliers and contract manufacturers/laboratories
• Partner with Purchasing, R&D, and Manufacturing on supplier selection, changes, and disqualification decisions

• Lead and document investigations involving NCRs, QIRs, OOS results, and customer product complaints from initiation through closure
• Conduct structured root cause analysis using methodologies such as 5 Whys, Fishbone/Ishikawa, fault tree analysis, and process/material trend review
• Coordinate with Manufacturing, QC, R&D, Process Engineering, and external laboratories to investigate potential root causes
• Define, assign, and track CAPAs and effectiveness checks in accordance with FDA and customer expectations
• Maintain and monitor open investigations based on risk, target dates, and customer commitments
• Draft customer-facing investigation responses, technical justifications, and waiver documents as needed
• Maintain investigation records and supporting CAPA evidence to ensure traceability and audit readiness
• Identify and escape systemic or recurring quality issues

• Perform periodic audit trail reviews of GMP electronic records and systems, including ERP and laboratory/instrument systems
• Support data integrity controls consistent with ALCOA+…