englewoodlab1mo ago

New

Quality - QA Systems & Compliance Associate

United States·Patersonmid

OtherCompliance Associate

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Quick Summary

Overview

QA Systems & Compliance Associate Location: Totowa,

Technical Tools

OtherCompliance Associate

Responsibilities

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2–4 years of experience in quality engineering, quality investigations, CAPA, auditing, quality systems, or related Quality functions within a regulated manufacturing environment.

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Experience in cosmetics/personal care, OTC drug, pharmaceutical, or contract manufacturing is preferred.

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Experience planning or conducting internal audits and supporting customer, external, or regulatory audits/inspections.

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Supplier qualification and supplier quality management experience is preferred.

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Working knowledge of root cause analysis methodologies and CAPA management.

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Familiarity with IQ/OQ/PQ, validation/qualification, calibration/metrology, audit trail review, and ALCOA+ data integrity principles.

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Familiarity with Lean, Six Sigma, Kaizen, PDCA, DMAIC, and other continuous improvement methodologies.

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Familiarity with statistical and quality tools such as FMEA, control charts, Pareto analysis, and trend analysis.

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Working knowledge of cGMP, 21 CFR 210/211, FDA investigation/CAPA requirements, and ISO 22716.

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Familiarity with ISO 19011 auditing guidelines is preferred.

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Nice to Have

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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.

Requirements

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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.

What We Offer

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✓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

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.

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.