Quality - QA Systems & Compliance Associate

Englewood Lab, Inc. · United States

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 Position Summary 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. Key Responsibilities Auditing

• 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.

• Bachelor’s degree in a scientific, quality-related, engineering, or related discipline, or an equivalent combination of education and experience.
• Engineering background preferred.
• 2–4 years of experience in quality engineering, quality investigations, CAPA, auditing, quality systems, or related Quality functions within a regulated manufacturing environment.
• Experience in cosmetics/personal care, OTC drug, pharmaceutical, or contract manufacturing is preferred.
• Experience planning or conducting internal audits and supporting customer, external, or regulatory audits/inspections.
• Supplier qualification and supplier quality management experience is preferred.
• 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.
• Familiarity with ISO 19011 auditing guidelines is preferred.
• CQA, CQE, Certified Lead Auditor, Six Sigma, or equivalent certification is preferred or considered a plus.
• 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.

• This is a full-time, onsite position based at Englewood Lab, Inc., 20 Campus Road, Totowa, New Jersey.
• Standard schedule is Monday through Friday, 5 days onsite.
• Additional hours may occasionally be required to support audits, regulatory inspections, investigations, or other deadline-driven activities.
• Occasional travel may be required for supplier and contract laboratory audits.

• Work is performed primarily in an office environment with regular visits to manufacturing, warehouse, and laboratory areas for audits, investigations, and process observations.
• Must be able to operate a computer and standard office equipment for extended periods.
• Ability to lift and carry up to 10–15 pounds.
• May be exposed to fragrances, cosmetic raw materials, noise, and temperature variations while on the production floor.
• Required PPE and cGMP gowning procedures must be followed.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

• Medical, Dental, and Vision Insurance
• Company-paid Life / AD&D and Disability Insurance
• 401(k) Retirement Plan with Employer Match
• Paid Time Off (PTO) and Company-Paid Holidays
• Special Paid Leave for Employees’ Personal Events
• Year-End Gift
• Employee Referral Program
• Additional benefits as outlined in the Employee Handbook