Job Information
Adecco US, Inc. REMOTE CAPA Manager in Irving, Texas
Adecco is currently assisting a Fortune 8 company and is one of the largest providers of healthcare supply chain management solutions, retail pharmacy, medical & pharmaceutical supplies, healthcare technology, community oncology and specialty care in recruiting for a REMOTE CAPA Manager. Apply Now!
Requirements:
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 and 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
Schedule: Weekdays - 8:00am - 5:00pm but will be flexible while still ensuring we meet the 40 hour week
Pay Rate: The wage for this position is between $65 and $75. Hourly wage may depend upon experience, education, geographic location and other factors.
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
What do we need from you?
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 and 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
Click on apply now for instant consideration!
This employer requires all employees, temporary labor, consultants, and contractors to be fully vaccinated against COVID-19 by their start date, subject to approved medical or religious exemptions.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.
Pay Details: $65.00 to $75.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adeccousa.com/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.