Patient Safety Operational Specialist
AbbVie
2 months ago
On-site
Branchburg, NJ
$78,500 - $141,000 USD yearly
Operations
Supports AbbVie’s global quality assurance function, suppliers, and manufacturing sites for medical devices and combination products by providing in-house support to ensure product meets customer and regulatory requirements. Supports analysis and data collection for product or quality system issues intended to support continuous improvement. Involved in support of regulatory inspections for medical devices and combination products.
Responsibilities:
- Quality Operations: Process and maintain SOPs; compile quality data and trends for Quality Management and Product Reviews.
- Quality and Regulatory Compliance: Support and manage regulatory inspections and track inspectional responses; serve as training coordinator.
- Quality Systems: Maintain knowledge of current and emerging GxP requirements and global quality trends; support and execute changes to quality standards/policies to ensure conformance.
- Organization Effectiveness and Strategic Direction: Draft memos/letters; compose correspondence; schedule meetings; set up filing systems; gather information; answer questions on policies/procedures; prepare reports; compile statistics; set up databases.
- Assist with special projects by collecting and collating documents/materials.
- Assist functional areas to compile and generate reports, timelines, correspondence, and presentations.
Qualifications:
- Bachelor’s degree in a scientific discipline or equivalent experience.
- 5+ years combined experience in Manufacturing, QA, and/or R&D in pharmaceutical, biologics, device, or chemical industry.
- Demonstrated knowledge of quality systems and CAPA (corrective and preventive action) 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.
- Proficient in computer skills, database management, spreadsheets, project management, presentations, word processing, flowcharting, and similar software.
Responsibilities:
- Quality Operations: Process and maintain SOPs; compile quality data and trends for Quality Management and Product Reviews.
- Quality and Regulatory Compliance: Support and manage regulatory inspections and track inspectional responses; serve as training coordinator.
- Quality Systems: Maintain knowledge of current and emerging GxP requirements and global quality trends; support and execute changes to quality standards/policies to ensure conformance.
- Organization Effectiveness and Strategic Direction: Draft memos/letters; compose correspondence; schedule meetings; set up filing systems; gather information; answer questions on policies/procedures; prepare reports; compile statistics; set up databases.
- Assist with special projects by collecting and collating documents/materials.
- Assist functional areas to compile and generate reports, timelines, correspondence, and presentations.
Qualifications:
- Bachelor’s degree in a scientific discipline or equivalent experience.
- 5+ years combined experience in Manufacturing, QA, and/or R&D in pharmaceutical, biologics, device, or chemical industry.
- Demonstrated knowledge of quality systems and CAPA (corrective and preventive action) 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.
- Proficient in computer skills, database management, spreadsheets, project management, presentations, word processing, flowcharting, and similar software.