JOB SUMMARY

The Q.A. Record Specialist is responsible for the management and maintenance of master documents for manufacturing, packaging, and testing. The QA Record Specialist assists management in accomplishing projects, meeting commitments, developing departmental systems, and overall assurance of accurate and appropriate processing of Master Batch Record documentation, issuance of batch records, testing specifications, and laboratory records.

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

Analyzes and coordinates scheduled production batches to ensure the availability of complete and accurate manufacturing documents. Prioritizes the issuance of all necessary and appropriate documents for each scheduled product, calculates and assigns product expiration date, and assures critical information such as product ID and strength. Recognizes and resolves documentation discrepancies. Communicates any such occurrence and corrective action to the Manager and other QA Record Specialists. Assists management in the orientation of and provides training for newly hired QA Record Specialists. Manages documentation-related projects to support the needs of management. Develops appropriate batch records to meet the documentation requirements of validation protocols, special studies, and component qualification. May attend daily and/or weekly production scheduling meetings and ensure timely completion and issuance of all documents required for scheduled production. Monitors the approved Production Schedule continuously to ensure timely response to changing requirements. Performs other duties and responsibilities as delegated by QA Documentation/MQA Disposition Management.

REQUIREMENTS

Undergraduate degree (preferably Chemistry or Biology) or an appropriate combination of education, training, and experience. 3-5 years' experience in the pharmaceutical industry. Excellent communication, writing, and proofreading skills. Computer skills required. The max pay rate is $24.50/hr for this position