What are the responsibilities and job description for the Business Process Specialist position at Infosoft, Inc?
Here are the job position details for your review:
Job Title: Business Process Specialist - USA Sales Partner Management
Pay Rate: $40 to 45/Hr
Duration: 12 Months
Location: Malvern, PA
Shift Timings: 1st Shift - (8 AM - 5 PM)
Subject matter expert who can confidently advise and critically review Corrective and Preventive Actions (CAPAs), quality management systems, and sales partner processes and facilitate continuous improvement through the implementation of solutions and effectiveness monitoring.
Your primary business focus is process support to USA Sales Partner Management.
Responsibilities
- Critically review and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow
- Support various day-to-day sales partner processes required by company Directives, Policies, and Internal Controls. These processes are subject to internal and external periodic audits.
- Support continuous improvement activities from conception, issue identification, through implementation of solutions, and effectiveness monitoring
- Responsible for performing timely, detailed process tasks like assessing issue descriptions, reviewing data sources, assisting with root cause analysis, and quality problem-solving
- Project manage all aspects of assigned activities which includes gaining the commitment of cross-functional resources, scheduling team meetings, and ensuring deliverables per project timelines.
- Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement
Required Skills:
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- At least a bachelor's degree in an engineering or scientific-related field or other equivalent experience working in a medical device environment
- 3 years' practical experience with CAPA, Project / Process Management
- Able to understand, analyze, and solve complex problems
- Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
- Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971
- Demonstrated ability to partner with business stakeholders and effectively interact with and influence employees, and managers on all levels
- Strong Project Management skills, including the ability to project manage CAPA activities
- Strong reasoning and logical thinking skills
- Excellent written and verbal communication skills in English
Job Types: Full-time, Contract
Pay: $40.00 - $45.00 per hour
Application Question(s):
- "Please share alternate email"
Experience:
- Project Management: 1 year (Required)
- Review Corrective and Preventive Actions (CAPAs): 1 year (Required)
- 21 CFR Parts 803, 806, and 820: 1 year (Required)
- ISO 13485, ISO 9001, and ISO 14971: 1 year (Required)
Work Location: In person
Salary : $40 - $45
