Noven Pharmaceuticals, Inc: QA Inspector - TEMP

QA Engineer is needed in Miami, United States.

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Client: Noven Pharmaceuticals, Inc.

Location: Miami, FL

Contract: Temporary

Perform Quality Assurance tasks

• Sampling, inspections, and tests
• Ensure compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations
• Document all work performed
• Inform management of deviations from established standards/procedures

Inspect and approve

• Rooms, lines, and equipment prior to use by manufacturing and R&D personnel
• Components for in-process operations
• Manufacturing areas for compliance with internal SOPs, cGMPs, and FDA/DEA regulations

Document work activity

• Record all work activity in appropriate batch records, forms, and logs for accuracy and compliance

Sample and test

• In-process items and finished products
• Perform required inspections and testing
• Process and distribute samples to different departments

Review records

• Ensure cGMP compliance for accuracy and thoroughness

Inform management

• Report problems, failures, and deviations from established internal and regulatory standards

Apply disposition sticker

• Components and in-process materials

Issue QA Alerts

• Whenever any questionable component, in-process material, or product is identified

Perform swab and Rodac Plate sampling

Perform transactions in JD Edwards

Education / Experience

• High school diploma or equivalent
• Basic computer skills required
• Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division)
• Ability to read, write, communicate and follow instructions (verbal and written) in English is required

Judgment / Decision Making

• Duties performed within a framework of departmental or functional protocol requiring a minimal degree of original thinking