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Please note that this is a 9 month contract position.
QUALIFICATIONS:
Bachelors Degree in Biology, Chemistry, Chemical Engineering preferred or minimum of 3 to 5 years
Medical device (MD&D) /Pharmaceutical equivalent industry experience is required.
Use of ERP system for performing material transactions/moves/quantities/cycle counts.
Strong Proficiency in MS Office.
Ability to demonstrate effective oral and written communication skills.
Knowledge of Quality Information Systems (Trackwise, Windchill (PLM), cGMPs).
Ability to read, write and speak English.
SUMMARY:
Responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to formulation, filtration, purification, reagent preparation, processing of plasma by protein fractionation, Viresolve and Viral Inactivation processes according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. Responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.
RESPONSIBILITIES:
Perform and understand detailed processes to include: Equipment CIP/SIP processes, Fractionation, Reagent Preparations, Viresolve and Viral Inactivation and Filtration.
Accurately complete (and perform review of documentation when needed) documentation in batch records, logbooks, forms and other GMP documents.
Perform in-process testing as required by processes and procedures utilizing instrumentation, such as: (pH and conductivity meters and hydrometers, scales, pumps, concentration/dia-filtration skids and chromatography columns (list is not all inclusive.)
Clean, prepare and assemble equipment for processing operations including stationary tanks, filter housings, collection vessels, centrifuges, and mixing apparatus.
Verify and enter production parameters per SOP and Batch Records.
Operate and troubleshoot equipment in clean room and non-clean room environment.
Train other employees on batch record steps and associated processing related steps and procedures.
Perform other work-related duties as assigned.
OTHER DUTIES:
Ability to work with human blood products (plasma), methanol and chemicals.
Ability to work in clean/cold room environment during the work day.
Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
Support and contributes to projects and nonconformance investigations and performs manufacturing/validation activities with assistance from a SME.
Adhere to EHS policies and attend all required EHS training.
Ability to lift up to 50 lbs.
Applicants must provide their phone number. Reference job number A3440.
NetSource, Inc.
