Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Municipio de Juncos

Description

Company Description

A leading Bio- Pharma industry


Job Description

Manufacturing operations experience must have been in an FDA regulated environment (Bio-Tech / Pharma / Medical Devices).
Experience in Quality Record management is required. This implies Non-Conformances (Deviations), CAPAs, CAPA EVs, Change Control records, etc.

The Manufacturing Specialist will be responsible for managing and executing total quality management systems for the External Supply organization (Raw Materials Categories).
The Specialist is expected to execute nonconformance, CAPA, CAPA-EV, SICAR, EN, Change Control and metrics oversight responsibilities. The Specialist processes, investigates and acts as first responder to deviations. Addresses and expedites product and raw material deviation under the company's quality management system procedures, and ensures compliance with regulatory agencies. Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses. Maintains unified product defect investigation operating procedures. Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent re-occurring events. Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures. Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting. May serve as the primary point of contact between External Supply and the site teams as well as External Supply Quality to ensure the quality of raw materials used at the sites.


Qualifications

Doctorate degree
OR
Master’s degree in Sciences and 3 years of Manufacturing Operations experience
OR
Bachelor’s degree in Sciences and 5 years of Manufacturing Operations experience.
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Additional Information

EXPERIENCE REQUIRED:

PREFERRED QUALIFICATIONS
• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Participate and help lead cross-functional teams
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.PREFERRED QUALIFICATIONS
• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Participate and help lead cross-functional teams
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

  • ms project