Quality Assurance Systems & Compliance Coordinator

Title: QA Systems & Compliance Coordinator

Location: Totowa, NJ (Onsite)

Employment Type: Full-Time | Non-Exempt (Hourly)

Reports to: QA Systems & Compliance FG Records Lead or QA Documentation Lead

Department: Quality Assurance

Organizational Relationships: Works closely with the QA Systems & Compliance team (FG Release, FG CoAs, FG Records), the QA Documentation team, QC, Manufacturing, Packaging, Warehouse, Regulatory Affairs, and customer quality contacts.

Responsibility

Summary:

Responsible for coordinating finished goods (FG) records for OTC drug and cosmetic products, supporting the creation of FG Certificates of Analysis (CoAs), and supporting customer communication to ensure timely, accurate responses and high-quality documentation. Oversees document control processes, including organizing, tracking, and verifying records for accuracy and compliance. Assists with quality assurance activities such as investigations, inspections, and reporting. Reviews customer samples to be sent to the customer, tracks approval status, and updates customer quality systems.

Ensures adherence to SOPs and maintains data integrity across all records and systems.

The QA Systems & Compliance Coordinator is responsible for supporting the company's business events through a variety of tasks, including:

• FG Records Coordination: Coordinate the collection, review, and reconciliation of finished goods records (e.g., batch, packaging, and release documentation) for OTC drug and cosmetic products to confirm they are complete, accurate, and compliant with good documentation practices (GDP).
• FG Records Follow-Up: Identify missing, incomplete, or incorrect entries and documents, and follow up with Manufacturing, Packaging, QC, and other departments to obtain corrections before records are filed or released.
• FG CoA Support: Support the creation of FG Certificates of Analysis (CoAs) by compiling test results and batch/lot information, verifying data against approved specifications and source records, preparing CoAs for review, and maintaining a CoA tracker to support timely issuance.
• Customer Support and Communication: Facilitate timely and accurate responses to customer requests, ensuring quality documents and communication meet customer needs.
• Quality Documentation and Compliance: Ensure accuracy and completeness of quality documents, maintain trackers, and update customer quality systems via their portal.
• Quality Assurance and Investigation: Support quality investigations, line trials, and issue reports to ensure compliance with regulatory requirements.
• Customer Samples: Review customer samples to be sent to the customer and track approval status.
• Document Control: Scan, upload, and label documents accurately into electronic filing systems, and file and organize physical and electronic records according to established procedures.
• Reconciliation and Tracking: Perform document reconciliation to ensure records are complete and accurate, and maintain logs, trackers, and spreadsheets for document control and status tracking.
• Record Retrieval and Audit Support: Retrieve documents and records for internal teams, customers, audits, and inspections, and keep records organized and audit-ready.
• Workflow Coordination: Serve as a point of coordination across FG records, FG release, and FG CoA activities, prioritizing work against customer and shipment deadlines and escalating delays or recurring documentation issues to the FG Records Lead or QA Documentation Lead.
• Compliance: Follow SOPs, confidentiality guidelines, and data integrity requirements (ALCOA+) for all electronic and paper records, and perform general administrative support such as data entry and copying as needed.
• Other Duties: Conduct any other assignments as directed by the FG Records Lead, QA Documentation Lead, or Director of Quality Assurance.

• High school diploma or equivalent (Associate's or Bachelor's degree preferred).
• 1 - 3 years of experience in quality assurance, document control, records management, or administrative support, preferably in a regulated manufacturing environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Strong attention to detail and ability to follow instructions and SOPs.
• Good written and verbal communication skills, including professional communication with customers.

• Experience in a GMP-regulated environment (OTC drug, pharmaceutical, or cosmetics) and…