Full-Time
QA Systems & Compliance Associate
Englewood Lab
Compensation Overview
$50k - $60k/yr
+ Discretionary bonus
Totowa, NJ, USA
In Person
Five days onsite per week are required. Occasional travel may be required for supplier and contract laboratory audits.
Bachelor's
Category
 Manufacturing Quality & Test (1) |
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Required Skills
ERP
Six Sigma
Metrology
GMP
Word/Pages/Docs
Quality Assurance (QA)
Excel/Numbers/Sheets
Requirements
- A bachelor's degree in a scientific, quality-related, engineering, or related discipline, or an equivalent combination of education and experience.
- Two to four years of experience in quality engineering, quality investigations, corrective and preventive action, 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 and inspections.
- Working knowledge of root cause analysis methodologies and corrective and preventive action management.
- Familiarity with IQ/OQ/PQ, validation and qualification, calibration and 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 and corrective and preventive action 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.
- Ability to operate a computer and standard office equipment for extended periods.
- Ability to lift and carry up to 10–15 pounds.
- Required personal protective equipment and cGMP gowning procedures must be followed.
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 and registrar audits, and regulatory inspections, including FDA inspections.
- Coordinate responses to external and customer audit observations and track related corrective and preventive actions 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.
- 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 nonconformance reports.
- Issue and manage Supplier Corrective Action Requests and track corrective actions and effectiveness.
- Support and maintain quality agreements with suppliers and contract manufacturers or laboratories.
- Partner with Purchasing, R&D, and Manufacturing on supplier selection, changes, and disqualification decisions.
- Lead and document investigations involving nonconformance reports, quality investigation reports, out-of-specification results, and customer product complaints from initiation through closure.
- Conduct structured root cause analysis using 5 Whys, Fishbone/Ishikawa, fault tree analysis, and process or material trend review.
- Coordinate with Manufacturing, QC, R&D, Process Engineering, and external laboratories to investigate potential root causes.
- Define, assign, and track corrective and preventive actions 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 corrective and preventive action 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 enterprise resource planning and laboratory or 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 corrective and preventive action activities.
- Identify, lead, and support continuous improvement initiatives focused on product quality, compliance, and operational efficiency.
- Analyze trends involving nonconformance reports, quality investigation reports, out-of-specification results, complaints, and audit findings to identify systemic issues and improvement opportunities.
- Apply Lean, Six Sigma, Kaizen, PDCA, and DMAIC methodologies.
- Participate in and facilitate cross-functional improvement initiatives.
- Develop, monitor, and report quality metrics and key performance indicators using FMEA, control charts, Pareto analysis, and trend analysis.
- Support process, material, and document changes through the change control process.
- Author and revise standard operating procedures, work instructions, forms, and other Quality System documentation.
- Work cross-functionally with QA/QC, Manufacturing, R&D, Process Engineering, Warehouse, Purchasing, Regulatory Affairs, external laboratories, suppliers, auditors, and customer quality contacts.
- Work primarily in an office environment with regular visits to manufacturing, warehouse, and laboratory areas for audits, investigations, and process observations.
Desired Qualifications
- An engineering background.
- Experience in cosmetics or personal care, over-the-counter drug, pharmaceutical, or contract manufacturing.
- Supplier qualification and supplier quality management experience.
- Familiarity with ISO 19011 auditing guidelines.
- CQA, CQE, Certified Lead Auditor, Six Sigma, or equivalent certification.