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Senior Incoming Laboratory Analyst

Summary:

Provides support to the area supervisor in the coordination of the Incoming Laboratory activities and duties that require a Chemist license in addition to perform and review sampling, inspection, and testing related to Raw Materials/Excipients, Active Product Ingredients (API), sterile materials and Packaging Components received at BMS Manati and assuring compliance with applicable regulations (EU, Japan, Brazil, FDA requirements).

This position must to comply with the Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job. 

Responsibilities:

1.    Performs testing, sampling and  inspection for raw materials/excipients, packaging components, intermediate products, retain samples , finished products and Inter Laboratory Qualifications as per current Testing Standards and/or monograph, USP, NF or validation protocols (where applicable).
2.    Performs the disposition of raw materials/excipients, active product ingredients (API) and packaging components according to results obtained.
3.    Performs investigations of non-conforming results and resolution of investigations.
4.    Performs and review required testing of materials and products in accordance with BMS specifications and/or applicable compendia.
5.    Leads process validations, laboratory equipment qualifications, and method transfers activities. 
6.    Initiates and provides follow up to completion of change control for Testing Standard, methods and or equipments (new or retirement).
7.    Recommends and make changes to documents such as:  SOPs, protocols, methods, operational procedures, etc.
8.    Approves cleaning records performed on Incoming API Sampling and Raw Material Incoming Sampling Rooms.
9.    Provides training support for Manufacturing and QA personnel (e.g., expiration dating SOP, etc.) and to new members on approved monographs and procedures following applicable training SOP.
10.    Conducts internal audits (e.g., housekeeping, logbook audits, etc.).
11.    Assists Incoming Laboratory Supervisor in the creation, distribution of weekly schedule according manufacturing requirements or products deadlines.

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12.    Coordinates laboratory schedule, approve laboratory investigations and inform management during the Laboratory supervisor absence such as sick period or vacations. 
13.    Represents Incoming Supervisor in Production Meetings and work plans of the area in coordination with Planning Department schedules to comply with area metrics.
14.    Provides support in the approval of final Certificate of Analysis generated by the area or Product Release for raw materials, packaging components or finished products manufactured at BMS Manati.
15.    Ensures that have approved validated methods and specifications, robust systems and adequate facilities to perform required testing when is involved in testing of finished products, API’s, biological drug substance...