Paga: 12.48 como Temporero por hora
Primer Turno
DUTIES & RESPONSIBILITIES
The purpose of this position is to perform the coordination activities to ensure Building 6 manufacturing documentation integrity and compliance with the cGMP. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Generates commercial and experimental Batch Records for Production.-makes copy from Bath Record Master File
-prints all applicable documentation from Documentation Control A (DCA) and SAP systems.-prints label (lot number, product code and name and adds lot additional information.-assigns seals to be placed on the final product drums (Compression, Coating and Printing) -compares all batch records documentation versus production orders and BOM/BOS to assure the documentation corresponds to the product lot. - verifies that batch records, production orders and BOM/BOS data are the same if not report any discrepancy immediately to the corresponding department (MTDP or Materials) for prompt correction before distribution for manufacturing process.
2. Generates cleaning checklist packages and distributes to Manufacturing supervisor ensuring that the cleaning forms are the current version approved in DCA.
3. Receives daily executed Batch Records, removes internal documentation and keeps all GMP documentation required by BMS procedures and; refers to the supervisor any document’s discrepancies for correction before delivering to QA area (Product Compliance Release).
4. Gives follow up to manufacturing areas to ensure documentation cycle time completion (not more than 2 working days), production schedule commitment and reports any finding on the release attainment team.
5. Performs periodic manufacturing documentation audits as scheduled.
6. Verifies approved Packaging Art Components (BOS- Build of Specification) and creates labels accordingly.
8. Maintains, guarding and handling all manufacturing files: Master Batch Records, Batch Record, Log Books, cleaning registers/checklists new and executed forms, security seals, printed materials and any batch record supporting document.
9. Receives and makes reconciliation of manufacturing container seals by number according to Security Guidelines and GMPs.
10. Coordinates with Purchasing Department Printing Forms Requisitions and maintains an adequate supply of forms for the nufacturing area.
11. Performs the reporting consumption of material, man hours, transfer orders (TO) and transfer request (TR) in absent of the Manufacturing Coordinator and; provides training to new hires, regular or temporary employees on applicable guidelines, procedures, batch records and cleaning forms.
12. Maintains Building 6 Procedures Binders and procedures matrix to ensure that latest approved version are in place and, replace any obsolete version. This include the reconciliation of removals of obsolete versions.
13. Assists on Internal/External audits by providing any required documentation as the manufacturing documentation custody
.
MINIMUM REQUIREMENTS
Bachelor Degree * One (1) year of experience in manufacturing documentation or Quality Control administration in a Pharmaceutical industry * Computer knowledge is required (Word, Excel, PowerPoint, Internet) * Excellent communication verbal and written skills (English/Spanish). * Excellent analytical skills with details * Good mathematical skills
Team Player and ability to work with people at different levels. * Typing and Filing skills * Excellent organization skills
Self-starter and motivator. * Able to work with minimum supervision, a must. * Good proof-reading skills.
Good knowledge of office machines, such as fax, copiers, etc.
Job Type: Full-time
Salary: $12.48 /hour
Experience:
Manufacturing Documentation: 1 year (Required)
Pharmaceutical: 1 year (Required)
Education:
Bachelor's (Required)
Benefits:
None
Schedule:
Monday to Friday
