Quality Assurance Systems & Compliance Coordinator

Englewood Lab, Inc.•Totowa, NJ

7d•$17 - $21•Onsite

About The Position

The Quality Assurance Systems & Compliance Coordinator is 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. This role oversees document control processes, including organizing, tracking, and verifying records for accuracy and compliance. The coordinator also assists with quality assurance activities such as investigations, inspections, and reporting. They review customer samples to be sent to the customer, track approval status, and update customer quality systems. A key aspect of this role is ensuring adherence to SOPs and maintaining data integrity across all records and systems.

Requirements

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.

Nice To Haves

Experience in a GMP-regulated environment (OTC drug, pharmaceutical, or cosmetics) and familiarity with batch or finished goods record review.
Familiarity with Certificates of Analysis and how test results and specifications are reported.
Experience with ERP, document management, or customer quality portal systems.
Knowledge of good documentation practices (GDP) and data integrity principles (ALCOA+).
Willingness to learn new processes and systems.

Responsibilities

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).
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.
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.
Facilitate timely and accurate responses to customer requests, ensuring quality documents and communication meet customer needs.
Ensure accuracy and completeness of quality documents, maintain trackers, and update customer quality systems via their portal.
Support quality investigations, line trials, and issue reports to ensure compliance with regulatory requirements.
Review customer samples to be sent to the customer and track approval status.
Scan, upload, and label documents accurately into electronic filing systems, and file and organize physical and electronic records according to established procedures.
Perform document reconciliation to ensure records are complete and accurate, and maintain logs, trackers, and spreadsheets for document control and status tracking.
Retrieve documents and records for internal teams, customers, audits, and inspections, and keep records organized and audit-ready.
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.
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.
Conduct any other assignments as directed by the FG Records Lead, QA Documentation Lead, or Director of Quality Assurance.