Manufacturing Associate - Pharmaceuticals

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Responsibilities

The Manufacturing Associate IV position reports to Supervisor/Manager Manufacturing at Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. Additional responsibilities include:

Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures

Informs Supervisor on progress of projects, transfer of data, process details, etc.

Executes batch records according to GMP and site quality standards

Generates Batch Records, SOPs and Protocols as required

Responds to off-hour alarms as assigned by the Manager Manufacturing

Executes manufacturing cleanroom changeover and activation

Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment

Supports Emergent QA during audits and regulatory inspections

Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

Physical Abilities

Type/keyboard, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, lift/carry 20lbs

Equipment Used

Phone, copier, computer, copier

Mental Functions

Organize/coordinate, analyze/interpret, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, prepare transaction documents


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