Easter Seals Jobs

capa manager.

• irving , texas (remote)

• posted 6 days ago

job details

summary

• $65 - $75 per hour

• contract

• bachelor degree

• category computer and mathematical occupations

• reference1056085

job details

job summary:

Job responsibilities:

• The CAPA Manager will provide Corrective and Preventive Action (CAPA) process leadership, with a focus on driving improvements in product and process performance, and proper identification and appropriate addressing of issues relating to nonconformances.

• Monitor and respond as needed to escalated issues within the war room setting per the major incident management SOP.

• The CAPA Manager will be responsible for the effectiveness of the CAPA Process and related systems.

• Chronologically document the high-level actions completed in response to the issue, so that as needed, response effectiveness can be reviewed and improved.

• Multi-task multiple high priorities while maintaining a high level of timely communication and documentation accuracy.

• Recognize when issue escalation is needed and successfully execute needed communication and follow up.

• Complete data queries as needed to support enterprise-wide requests.

• Ability to support and facilitate multiple teams in parallel toward the determination of Root Cause using standard data gathering and problem-solving methodologies.

• Closely monitor open CAPA activities and intervene as needed to facilitate their completion.

• Ensure accuracy of system entries and distributed information.

• Ensure data integrity of PHI related information is maintained.

• Ensure timely response to email and other forms of communication.

• Maintain professional accountability during challenging discussions.

• Assist in the establishment of metrics.

• Collaborate with cross functional teams to ensure correct issue ownership, closure of CAPA action items and effectiveness of closure.

• Responsible to ensure that the CAPA program meets all applicable requirements and regulations, including but not limited to ISO 9001:2015.

Requirements:

• Bachelor's degree or equivalent practical experience.

• Lean-Six Sigma training preferred (green or black belt)

• Knowledge of quality systems based on ISO 9001:2015 or similar.

• Expertise in the pharmaceutical, healthcare, and/or pharma healthcare consulting industry with focus on software development, data, and quality systems.

• Expertise with Corrective Action and Preventative Action processes and Root Cause problem solving methodology.

• Ability to work comfortably at all levels within the organization up to the senior management level is required.

• Sound organizational and planning skills with solid attention to detail.

• Critical thinking and problem-solving skills.

• strong Statistical and Analytical Skills

• strong Communication skills

• Excellent Documentation skills

• Project Management experience

• Flexibility and adaptability

• Ability to work without guidance from direct supervisor.

• Daily use of a computer and other computing and digital devices is required.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Ability to develop presentations.

• Technical knowledge and understanding of software development and infrastructure preferred

Job proficiencies:

• strong meeting facilitation skills

• Jira

• Confluence

• Excel

• Visio

• Word

• PowerPoint

• ServiceNow

• Outlook

• OneNote

• Teams

• Agile/scrum framework

• Root Cause Analysis

• 5 Whys

• Cause and Effect Diagramming

• Process Flow creation

• Standard flow

• Swim lane flow

• Data gathering and analysis

location: Irving, Texas

job type: Contract

salary: $65 - 75 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

Requirements:

• Bachelor's degree or equivalent practical experience.

• Lean-Six Sigma training preferred (green or black belt)

• Knowledge of quality systems based on ISO 9001:2015 or similar.

• Expertise in the pharmaceutical, healthcare, and/or pharma healthcare consulting industry with focus on software development, data, and quality systems.

• Expertise with Corrective Action and Preventative Action processes and Root Cause problem solving methodology.

• Ability to work comfortably at all levels within the organization up to the senior management level is required.

• Sound organizational and planning skills with solid attention to detail.

qualifications:

• Experience level: Experienced

• Education: Bachelors

skills:

• Six Sigma

• ManagerEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).Applications accepted on ongoing basis until filled.