The incumbent is responsible to assure adequate filing, management and retrieval of site GMP Documents within the Central Documentation Area. Accountable for the proper storage and safe-keeping of filed documentation, including retention of documents per BMS established requirements. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function. Receives, verifies, files and retrieves GMP documentation from all site functions and departments. Receives, verifies, files and retrieves all manufacturing batch records and related documents from bulk intermediates and active pharmaceutical ingredients (APIs), pharmaceutical finished products, raw materials, water and packaging components. Verifies records and enters all data on a timely basis into the computerized Records Management System Retrieves records based on client’s request. Keeps the records area well organized and disposes of records past their retention period following the established SOPs and BMS requirements. Acts as the custodian of GMP documentation (records), maintains control and make controlled copies of documents as requested. Maintains documentation records storage until their regulatory retention period and disposes at their expiry period following BMS Records Management policies. Requests manufacturing batch records and regulatory documents of former BMS Mayaguez and Barceloneta sites from the BMS contracted Records Filing company following the Records Management Procedure. Inventories, inspects, monitors and destroys retain samples from BMS Humacao based on regulatory expiration dates following site quality procedures. Receives, verifies, identifies, stores, retrieves, monitors, and enters the Retain samples received by QC/QA in the Sample Manager System (LIMS). Assists QC/QA site Management during regulatory inspections and special requests. Receives, files and retrieves original forms of Audit Observations/Audit Records in the central documentation area. Evaluates Retain samples as part of the APQR assessment. Verifies the Retain area temperature charts on a daily basis and changes the completed charts when required. Knowledge: Associate Degree in Administration Office or Sciences. Three (3) years experience in the pharmaceutical industry. Bilingual (Spanish/English) communication skills, both written and verbal. Filing and handling of regulatory documents. Previous experience supporting quality assurance or control activities and/or documentation preferred Skills: Ability to communicate/work effectively with others. Well organized and capable of adequately distributing daily workload. Ability to handle multiple priorities and large volume of work. Customer service oriented. Self-motivated, creative and teamwork oriented. Computer skills (Word, Excel, LIMS, etc.). Excellent manual skills to handle records boxes, Filing and hand-eye coordination in order to perform the retrieval of records and retains in a safe and adequate manner. CONCENTRATION AND VISUAL EFFORT: Extreme attention and coordination are considered critical due to the variety of documents and Retain samples handled (bulk intermediates, APIs, raw materials, waters, packaging components and expired records). Close attention is necessary at all times.
