Job Title: QA Record Specialist
Position Overview: The Q.A. Record Specialist is responsible for management and maintenance of master documents for manufacturing, packaging and testing. Assists management with respect to 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.
- Analyzes and coordinates scheduled production batches to assure 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, assures critical information such as product I.D., strength.
- Implements revisions to master batch records by accurately incorporating changes as specified by the approved document change request (DCR).
- Recognizes and resolves documentation discrepancies. Communicates any such occurrence and corrective action to Manager and other QA Record Specialist.
- 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.
- Manages a central file of Master Records that provides the facility with comprehensive historical records of all master formula documents and corresponding change control records.
- Develops appropriate batch records to meet the documentation requirements of validation protocols, special studies, component qualification.
- May attend weekly production scheduling meeting and assures timely completion and issuance of all documents required for scheduled production. Monitors the approved Production Schedule on a continuous basis to assure timely response to changing requirements.
- Performs other duties and responsibilities as delegated by QA Documentation/MQA Disposition Management.
- Undergraduate degree (preferably Chemistry or Biology) or appropriate combination of education, training and experience.
- 3-5 years experience in the pharmaceutical industry.
- Excellent communication, writing and proofreading skills.
- Computer skills required.
- Excellent verbal and written communication skills required.