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Quality Assurance (QA) Manager

San Juan, PR · Biotech/Pharmaceutical

Job Summary:

The Quality Assurance (QA) Manager will oversee the activity of the quality assurance department, developing, implementing, and maintaining a system of quality for the organization’s products and/or development processes.
 

Duties/Responsibilities:

  • Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
  • Identifies and sets appropriate quality standards and parameters for products.
  • Coordinates product testing processes.
  • Identifies and analyzes issues to recommend and facilitate solutions to these issues.
  • Reviews client, customer, and user feedback.
  • Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.
  • Batch Record Review, Validation process evaluation and approval, Product release, support New product introduction
  • Manage Quality Management Systems (Change Control, CAPA, Incidents, Complaints, etc)

Required Skills/Abilities:

Education and Experience:

  • Bachelor’s degree in Business, Engineering, or field related to the products being developed required.
  • Three to five years of experience in related field required with supervisory experience a plus.

Physical Requirements:

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.

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