Quality Control Document Reviewer

2 months ago

Deerfield Beach, United States SHL Group Full time

Job Overview

The QC Document reviewer plays a critical role in safeguarding product quality and ensuring compliance with regulations. Responsible for the review of documentation within the QC department not limited to incoming material inspection files, in-process inspection, test protocols, testing data review, and Batch Record documentation.

Main Responsibilities

Review and verify the completeness and accuracy of all batch records, including raw materials, processing steps, in-process controls, finished product specifications, and final packaging details. Ensure batch records adhere to established procedures, Good Manufacturing Practices (GMPs), and regulatory requirements (e.g., FDA regulations). Identify and document any deviations or discrepancies in batch records and initiate corrective actions as needed. Investigate and resolve discrepancies in batch records, working collaboratively with production and other departments. Maintain accurate and complete electronic or paper-based batch record documentation. May participate in audits of manufacturing processes and batch records. Contribute to the continuous improvement of batch record review procedures. Review incoming material inspection files, in-process inspection, protocol executions, and test data Performs product identification and traceability activities as required (e.g., Quarantine). Assists QC Management with segregating nonconforming materials per applicable procedures. Assists with the initiations and updates to QMS documents like procedures, work instructions, forms, technical documents, etc. Assist with SAP-related entries such as Inspection Plans and others. Performs other related duties as assigned.

Skills and Qualification

Associate Degree in Science or related area (equivalent experience will be considered) 3+ years in the pharmaceutical and/or medical device industry or equivalent with knowledge and experience conducting documentation review. Testing and Laboratory documentation review experience preferred. Ability to communicate effectively on a technical and professional level with customers, across organizations, and with all levels of management. Detail-oriented and able to work with a high volume of documents in a fast-paced environment. Strong analytical and problem-solving skills. Highly organized and process oriented. Experience in Pharmaceutical quality operations supporting manufacturing operations is strongly preferred. Strong understanding of the challenges of production scheduling/planning and customer requirements. Proficiency in Microsoft Office Suite is expected, and familiarity with industry-specific software for batch record management (e.g. SAP) can be a plus. Knowledge of FDA QSR requirements and ISO 13485, as they relate to quality control. Knowledge of Good Documentation Practices Knowledge of Good Manufacturing Practices

We Offer

Competitive compensation package Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast growing and innovative industry Position in a dynamic, international team of highly skilled professionals Various opportunities for personal and professional development within a global organization

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