Quality - QA Systems & Compliance Associate

Englewood Lab; Totowa (NJ); On-site; USD 50,000 - 60,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) with match

Paid Time Off

Job summary

Englewood Lab in Totowa, NJ, seeks a QA Systems & Compliance Associate to support quality systems, audits, CAPA, and data integrity across the site. The role collaborates with QA/QC, Manufacturing, R&D and Regulatory Affairs to ensure cGMP compliance and continuous improvement.

The position emphasizes audit readiness, supplier qualification, and cross-functional problem solving, with a strong emphasis on FDA and ISO standards.

Qualifications

• Bachelor’s degree in a scientific, quality-related, engineering, or related discipline.
• 2–4 years of experience in quality engineering, investigations, CAPA, auditing, or related functions.
• Experience with cGMP, ISO 22716, FDA expectations is preferred.
• Experience planning or conducting internal audits and supporting external audits is preferred.
• Familiarity with data integrity concepts and calibration/metrology.
• QA certifications (e.g., CQA/CQE) are a plus.

Responsibilities

• Plan internal quality system and process audits against cGMP/ISO/customer requirements.
• Prepare audit plans, checklists, reports, and classify findings by risk.
• Track corrective actions through closure and verify effectiveness.
• Support customer, supplier, and regulatory audits including FDA inspections.
• Lead CAPA investigations and root cause analyses; manage action plans.
• Support validation/qualification activities and data integrity controls.

Skills

Auditing

Data integrity

CAPA

Quality systems

GxP

Regulatory compliance

Root cause analysis

Process improvement

Cross-functional collaboration

Education

Bachelor’s degree in a scientific/quality-related discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

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

Quality Engineering & Validation

• 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

Supplier Qualification & Supplier Quality

• 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

Compliance, Investigations & CAPA

• 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

Data Integrity

• 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

Continuous Improvement

• 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

Qualifications

• 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

Work Location & Schedule

• 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 Environment & Physical Requirements

• 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

Compensation

$50,000 – $60,000 per year

The salary range reflects the anticipated base pay for this position. Actual compensation will be determined based on the candidate’s experience, qualifications, skills, and internal equity.

This position is also eligible for the company’s discretionary bonus program.

Benefits

• 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

Equal Opportunity Employer

Englewood Lab, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, pregnancy, veteran status, or any other characteristic protected by federal, state, or local law.

Englewood Lab, Inc. provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable law.