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Sr. Corrective Action and Preventive Action - Springfield, United States - Kindeva Drug Delivery
Description
Sr. Corrective Action and Preventive Action (CAPA) CoordinatorBrentwood, MO, USA
Req #1220
22 April 2024
SUMMARY:
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies.
Ready to work with purpose? Look no further, we are hiring for a motivated, talented, and passionate Senior Corrective Action and Preventive Action (CAPA) Coordinator to join our St.
Louis Missouri teamResponsible for facilitating the Corrective Action Preventive Action (CAPA) process in compliance with Meridian Medical Technologies policies, ISO 13485, US FDA regulatory requirements and other applicable device regulations.
Conducts regular trending as required by the regulations in order to identify quality related problems and ensure earlier detection of emerging issues.
Ensure thorough documentation of all CAPA procedural requirements. Responsible for ensuring Medical Device and Combination Product CAPA files are audit ready.ROLE RESPONSIBILITIES:
Facilitate the
CAPA Review Board (CRB) :
Facilitate, coordinate, and schedule periodic CAPA Review Board (CRB).
Maintain a routine schedule of meetings.
Ensure appropriate CRB quorum is represented and CAPA SMEs are invited as needed.
Call for agenda items.
Maintain a GMP record or repository of agendas and minutes.
Publish agenda, minutes, and attendees.
Assist with Quality System Oversight and CAPA Process:
Assist with the CAPA process by ensuring consistent and effective use of CAPA system SOPs and tools to build strong CAPA culture across the site.
Assist with proactively monitoring performance of the CAPA Quality System.Interface with individual CAPA Record owners to coach and facilitate progression through CAPA process.
Support the CAPA manager as needed and escalate identified resource constraints in a timely manner to management.
Verify that all procedural CAPA requirements are met. Periodically audit CAPA records to ensure the records are complete and audit-ready and contain all required objective evidence.
Monitor and enforce department compliance with
Meridian Medical Technologies
policies and procedures.
Provide coaching to technical experts on the problem-solving process and review technical content.
Develop and assist in the execution of corrective/preventative action plans as needed.
Assist with monitoring and coordinating the different quality sub-system feeders to the CAPA process such as Complaint Handling, Nonconformance Materials processes, Risk Management, Management Review, Internal Audits, etc.
Work with cross-functional teams to coordinate required activities of CAPAs (e.g., CAPA Evaluations, root cause analysis, Investigation Action Plans, Risk Assessments, Health Hazard Evaluation documents, etc.), and ensure CAPA records are documented appropriately.
Continuously drive process improvements for the CAPA system.Metrics:
Develop and monitor key CAPA metrics and provide input to device management reviews.
Ensure identified trends and issues are appropriately escalated and addressed promptly.
Develop metrics that are designed to communicate the overall health of the CAPA Quality System.
Review and interpret metrics and data. Determine action plans needed to maintain the CAPA Quality System in a state of compliance.
Prepare and present metrics to leadership team.
Continuously track CAPA actions and upcoming due dates to ensure timely completion.
Represent CAPAs during audits, Management Review, and CAPA Review Board meetings.
Training:
Train internal employees on CAPA Process, regulations and necessary activities.
Coach, mentor, and lead employees to instill best practices and promote career development.
Maintain CAPA training materials.
Assist with CAPA training program, including training for root cause analysis and technical writing.
BASIC QUALIFICATIONS:
B.S. in Engineering or other technical degree. The preferred candidate will have at minimum 2-5 years of experience with direct involvement in a devise CAPA role.
Demonstrated device CAPA knowledge and experience with US FDA 21 CFR CAPA requirements
Must be detail-oriented with expert knowledge of root cause analysis and key CAPA regulatory requirements (e.g. US, EU and other key geographies)
Ability to read, analyze and interpret technical procedures and government regulations. Proficient computer, proofreading, communication and customer service skills.
Strong interpersonal and influential skills
Excellent in communication and project management
Ability to work (and lead team efforts) on multiple priorities simultaneously
Capable of interfacing with multiple levels of people within the organization, including management, third party customers, and colleagues
Must be capable of organizing data from multiple sources, extracting key information to report metrics
Experience with word-processing, spreadsheet and presentation software (e.g. Adobe Acrobat, MS Word, Excel, Access and Visio)
Experience working in a cross-functional, matrix environment
Independent action and sound decision-making are essential for success in the position as decisions can impact regulatory filings, product release and compliance with GMP
Advanced analytical skills will be required to make competent decisions based on a review of analytical data. Decisions are made based upon knowledge and experience with input from the appropriate Quality Management personnel
Preferred Qualifications:
ASQ CQE
PHYSICAL/MENTAL REQUIREMENTS:
Ability to perform complex data analysis
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSPosition is on-site
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls.
Note that these activities may not be time bound to core hours.Must have the ability to work effectively under and manage strict production, time and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
Travel between Brentwood and Westport locations required.#J-18808-Ljbffr
