Manufacturing Operator

Aurobindo Pharma USA, Inc.•Durham, NC

About The Position

Manufacturing Operator is to perform all required Batch manufacturing, packing, equipment cleaning, area cleaning, in- process testing & sampling for Manufacturing and Packaging batches. Perform maintenance and troubleshooting of the equipment and machinery and handling controlled substances whenever required. Perform verifications using special instruments (Caliper, Balance, etc.)

Requirements

Familiar with proper documentation and correction practices
Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, Warehouse, Engineering and Supply Chain to meet finished product release goals
Be able to work long hours to support production requirements with flexibility to rotate 1st, 2nd or 3rd shift
Be available for overtime, including weekends, as needed for production support
Possess the ability to analyze information and make consistently good decisions
High School Diploma with some college courses, Associates Degree
1+ year experience performing Batch Manufacturing and Packing, In-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment
A familiarity with cGMPS, CFRs, OSHA and FDA regulations
Knowledge of deviations/incidents and CAPA

Responsibilities

Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and area.
Assist all required In-process testing & sampling of batches in progress and products to be packaged.
Assist Calibration of weighing and required equipment.
Perform packaging activities.
Perform other duties as assigned.
Handle various requests from departments for developmental or investigative reasons.
Complete all applicable training forms in a timely manner and forward to document control for archival.

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