Quality - QA Systems & Compliance Associate

QA Systems & Compliance Associate

Location: Totowa, New Jersey (Onsite)
Department: Quality Assurance – QA Systems & Compliance
Reports To: QA Systems & Compliance Lead
Employment Type: Full-Time / Exempt
Pay: $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
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• 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
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• Support oversight of the calibration and metrology program and elevate 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
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• 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 elevate 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+ principles across electronic and paper records.

• Support appropriate access controls, record review, and retention practices.

• Investigate and document data integrity events and support related remediation and CAPA activities.

• Identify, lead, and support continuous improvement initiatives focused on product quality, compliance, and operational efficiency.

• Analyze trends involving NCRs, QIRs, OOS results, complaints, and audit findings to identify systemic issues and improvement opportunities.

• Apply structured problem-solving and improvement methodologies such as Lean, Six Sigma, Kaizen, PDCA, and DMAIC
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• Participate in and facilitate cross-functional improvement initiatives.

• Develop, monitor, and report quality metrics and KPIs using tools such as FMEA, control charts, Pareto…