Patient Safety Operational Specialist
AbbVie
3 days ago
Remote friendly (Branchburg, NJ)
United States
$78,500 - $141,000 USD yearly
Operations
Responsibilities:
- Support AbbVie’s global quality assurance function for medical devices and combination products to ensure products meet customer and regulatory requirements.
- Analyze and collect data for product or quality system issues to support continuous improvement.
- Support regulatory inspections for medical devices and combination products.
- Process and maintain SOPs for the business segment; compile quality data and trends for Quality Management and Product Reviews.
- Provide support and manage regulatory inspections and track inspectional responses; serve as training coordinator.
- Maintain knowledge of current and emerging GxP requirements and quality trends; support and execute changes to quality standards/policies to ensure conformance.
- Handle organization effectiveness tasks (memos/letters, correspondence, scheduling, filing systems, basic reports, statistics, database setup).
- Assist with special projects by collecting and collating documents and materials.
- Compile and generate reports, timelines, correspondence, and presentations.
Qualifications:
- Bachelor’s degree required in a scientific discipline or equivalent experience.
- 5+ years of combined experience in Manufacturing, QA, and/or R&D in pharmaceutical, biologics, device, or chemical industry.
- Demonstrated knowledge of quality systems, CAPA, and tools for managing global quality performance in a regulated industry.
- Ability to work in a multinational, multicultural, highly matrixed environment.
- Strong oral and written communication skills.
- Proficient computer skills with hands-on experience in database management, spreadsheets, project management, presentations, word processing, and/or flowcharting software.
- Support AbbVie’s global quality assurance function for medical devices and combination products to ensure products meet customer and regulatory requirements.
- Analyze and collect data for product or quality system issues to support continuous improvement.
- Support regulatory inspections for medical devices and combination products.
- Process and maintain SOPs for the business segment; compile quality data and trends for Quality Management and Product Reviews.
- Provide support and manage regulatory inspections and track inspectional responses; serve as training coordinator.
- Maintain knowledge of current and emerging GxP requirements and quality trends; support and execute changes to quality standards/policies to ensure conformance.
- Handle organization effectiveness tasks (memos/letters, correspondence, scheduling, filing systems, basic reports, statistics, database setup).
- Assist with special projects by collecting and collating documents and materials.
- Compile and generate reports, timelines, correspondence, and presentations.
Qualifications:
- Bachelor’s degree required in a scientific discipline or equivalent experience.
- 5+ years of combined experience in Manufacturing, QA, and/or R&D in pharmaceutical, biologics, device, or chemical industry.
- Demonstrated knowledge of quality systems, CAPA, and tools for managing global quality performance in a regulated industry.
- Ability to work in a multinational, multicultural, highly matrixed environment.
- Strong oral and written communication skills.
- Proficient computer skills with hands-on experience in database management, spreadsheets, project management, presentations, word processing, and/or flowcharting software.