Quality Inspector 1

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Performed inspections as per corresponding documentation and following established procedures.

Responsibilities

Inspect labels, pid's and pouches visually to approve packing operations or other operations. Obtains samples, inspect samples to specifications, record inspection data and makes accept/reject decisions based on inspection findings with respect to specifications. Verifies dimensions, cavity measures, pressure, and other specifications of products, using measuring gauges and testing equipment such as optical comparator, micrometer, calipers, go-no-go gauges, pin gauges, microscope, air pressure gauges, and other testing instruments. Follows quality controls inspection criteria in order to release acceptable lots to store or reject lots prior operations for re-work. Reads written specifications, drawings, and procedures such as the Quality Control Inspection Procedures. Fill quality control records, information on shop orders, and maintains other control reports and documentation. Assists in training of new Q.A. Inspectors. Provides G.M.P/ Quality Manual reinforcement and conducts spot audits to manufacturing areas in order to assist production to achieve established goals. May be assigned to different workstations as product needs require. May use forklift or jack pallets for handling raw material incoming inspection area. Sets up and performs destructive and non-destructive test on material, parts, or product to measure performance, material characteristics, etc. Maintains quality control records, blueprints, procedures, and other documentation's accurate, updated, and properly organized in files. Assures all control documentation are prepared and attached to the corresponding lots. Assures that all equipment are adequately calibrated and informs Supervisor of any discrepancy. Assures raw material or products released to stores or for sterilization fulfill quality standards. maintains work area clean and in orderly conditions. Follow Clean Room Rules and Gowning Practices. Must use safety shoes in areas that require it or the required protective equipment of the assigned workstations. This applies to all area where safety shies area required. Maintains control of raw material quarantine area and printed materials, and discrepant materials in store. Works on priority orders when released before others to assure compliance with productions schedules. Assist the supervisor in any other duty as requested.

Qualifications

• High School graduate or equivalent.

• One (1) year experience in a similar position in an FDA regulated manufacturing environment preferred.

• Driver's license on heavy vehicles highly preferred.

• Knowledge of basic math concepts, graph interpretation, and use of procedure, and inspection methods.

• Knowledge of statistical process control techniques.

• Ability to read, understand drawings and written documents in English.

• Ability to work using testing instruments and manual equipment.

• Ability to be in a standing position for long periods of time.

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