Quality - QA Systems & Compliance Associate

Englewood Lab, Inc.•Totowa, NJ

7d•$50,000 - $60,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in a scientific, quality-related, engineering, or related discipline, or an equivalent combination of education and experience.
2–4 years of experience in quality engineering, quality investigations, CAPA, auditing, quality systems, or related Quality functions within a regulated manufacturing environment.
Experience planning or conducting internal audits and supporting customer, external, or regulatory audits/inspections.
Working knowledge of root cause analysis methodologies and CAPA management.
Familiarity with IQ/OQ/PQ, validation/qualification, calibration/metrology, audit trail review, and ALCOA+ data integrity principles.
Familiarity with Lean, Six Sigma, Kaizen, PDCA, DMAIC, and other continuous improvement methodologies.
Familiarity with statistical and quality tools such as FMEA, control charts, Pareto analysis, and trend analysis.
Working knowledge of cGMP, 21 CFR 210/211, FDA investigation/CAPA requirements, and ISO 22716.
Strong analytical, organizational, problem-solving, technical writing, and record-keeping skills.
High attention to detail and commitment to data integrity.
Proficiency in Microsoft Word, Excel, and PowerPoint.

Nice To Haves

Engineering background preferred.
Experience in cosmetics/personal care, OTC drug, pharmaceutical, or contract manufacturing is preferred.
Supplier qualification and supplier quality management experience is preferred.
Familiarity with ISO 19011 auditing guidelines is preferred.
CQA, CQE, Certified Lead Auditor, Six Sigma, or equivalent certification is preferred or considered a plus.

Responsibilities

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 escalate 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.
Participate in and facilitate cross-functional improvement initiatives.
Develop, monitor, and report quality metrics and KPIs using tools such as FMEA, control charts, Pareto analysis, and trend analysis.
Support process, material, and document changes through the change control process.
Author and revise SOPs, work instructions, forms, and other Quality System documentation.