Quality Analyst

AbbVie • Barceloneta, PR

8d

About The Position

Purpose: Describe the primary goals, objectives or functions or outputs of this position. Support manufacturing operations in the resolution of events and documentation discrepancies. Provide guidance for product/process impact analysis, investigations and risk based evaluations in support to plant events. <br/>Responsible for implementing and maintaining the effectiveness of the Quality System.

Requirements

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Quality/compliance management skills.
• This position requires knowledge of quality / compliance /Risk management as well as regulations and standards affecting biological products.
• Experience in Health care industry – 2 years.
• Experience in Pharmaceutical industry - 2 years.
• Total combined minimum years of experience required – 2 years.
• Fast paced and continuously changing environment.
• Subject to work with multiple interruptions and under reasonable pressure due to the nature and function of the area.
• Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.

Nice To Haves

• Master's degree: not required but desired.

Responsibilities

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents.
• Ensures all documents are in compliance with Abbvie global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records.
• Ensures that these documents have appropriate justifications according to product /process limits established.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level