Patient Safety Operations Specialist

Purpose

Describe the primary goals objectives or functions or outputs of this position.

Supports AbbVies global quality assurance function suppliers and manufacturing sites for medical devices and combination products by providing inhouse 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

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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 :

Qualifications

List required and preferred qualifications (up to 10). Include education skills and experience.

• 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.

Key Stakeholders 

Development Manufacturing Quality and Regulatory

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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