Patient Safety Operational Specialist
Company Description
About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
Supports AbbVies 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. This position supports the analysis and data collection for product or quality system issues intended to support continuous improvement. This position will also be involved in the support of regulatory inspections for medical devices and combination products.
The employee must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. Responsibilities Quality Operations - Responsible for the processing and maintenance of SOPs for the business segment. Compiles quality data and trends for Quality Management and Product Reviews. - Quality and Regulatory Compliance - Provides support and management of regulatory inspections and tracking inspectional responses. Training coordinator function responsibilities.
- Quality Systems - Maintains knowledge in both current and emerging GxP requirements and quality trends as they relate to Medical Device and Combination Products worldwide and supports and executes changes to quality standards/policies to ensure conformance.
- Organization Effectiveness and Strategic Direction - Types routine memos and letters, composes correspondence, schedules meetings, sets up filing systems, gathers information, answers questions on department and company policies and procedures, prepares basic reports, compiles statistics, and sets up databases.
- Assists with special projects, collecting and collating documents and materials as requested.
- Assists functional area, to compile and generate reports, timelines, correspondence and presentations.
Qualifications
- Bachelors degree required in a scientific discipline or equivalent experience.
- 5+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry
- Demonstrated knowledge of and experience with quality systems, corrective action and preventive action system, and other key tools for managing global quality performance in a regulated industry.
- Ability to work in a multinational, multicultural and highly matrixed environment.
- Strong communication Skills, both oral and written
- Proficient in computer skills and hands on experience with database management, spreadsheets, project management, presentations, word processing, flowcharting and/or any other similar type of software.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible toparticipate in our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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