Sr CAPA Analyst - Miami, FL | Biospace
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Sr CAPA Analyst

Beckman Coulter, Inc.

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Location:
Miami, FL
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
BEC007152
Salary:
Commensurate w/ exp
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The roles and responsibilities of CAPA Senior Analyst include but is not limited to the following:

CAPA Process and CAPA Review Board (CRB).  Participate in CAPA process and the CRB activities; participate in continuous alignment of CAPA program scope with strategic business objectives.
Perform and maintain advanced analyses of CAPA metrics developed and established by the CAPA manager, including measurement of trends and forecasts.
Analyze, maintain and report CAPA data aligned with leading and lagging KPIs; Trend, analyze, and report on the status of CAPA’s to the CAPA manager and escalate awareness of events that may contribute negatively to CAPA processes or outcomes.
Communicate CAPA data and information to CAPA manager on a regular basis; Provide information, as appropriate, to feed into the corporate CAPA process.
Work closely with CAPA/CRB manager to ensure CAPA activities are effectively coordinated. Provide support to CAPA/CRB manager to ensure compliance and timely completion of tasks assigned to process owners through the CAPA system.
Perform on-going monitoring and follow up with CAPA owners for CAPA Actions and CAPA requests.
Perform system administration activities, as required, in the electronic CAPA data system.
Assist CAPA PRP and ARP stakeholders with content entry and drive daily management of CAPA activities to ensure compliance to due date; provide support to establish and/or maintain processes to ensure CAPA findings, risks, recommendations and outcomes are clearly documented and communicated.
Provide support for the effectiveness and facilitation of CRB meeting (agenda, minutes, action items, next steps, follow-up, escalation, etc.).
Participate and provide support for effective and engaging training for CAPA system across organization.
PLRAs, CAPA Requests and CAPA Actions.  Monitor and track Post Launch Risk Assessment on-time delivery, monitor and track timeliness of CAPA requests, CAPA Action Plans; Oversight of CAPA Request activities within the BU to ensure timeliness and continuous improvement.  Work closely with CAPA/CRB manager on all CAPA monitoring activities.


Collaboration/Communication. Routinely communicate project goals, status, requirements, and deliverables to the CAPA/CRB manager. Perform other related duties and assignments as required. Work closely with CAPA management team to define, support, and implement functional infrastructure to support the needs of the Hematology, Cytometry and Urinalysis business.




Audits.  Provide a high level of professional support during internal and external audits; Verify accuracy and completeness of pertinent records and documentation.  Responsible for coordination of CAPA data analysis and data review processes for audit readiness.




Maintain professional and technical knowledge and continually update job knowledge by interacting with “Subject Matter Experts”, reviewing professional publications, establishing and maintaining personal networks, benchmarking state-of-the-art practices, participating in educational opportunities and professional societies, reading professional publications, and participating in educational opportunities.

Requirements

EDUCATION & CERTIFICATIONS:
Bachelor’s degree in Science and 5 years of relevant Quality/Regulatory Affairs experience or Master’s degree in Science and 3 years of relevant Quality/Regulatory Affairs experience or doctoral degree in field with 0-2 years or relevant experience
EXPERIENCE DESIRED:
Significant experience and understanding of quality assurance processes within the medical device industry with an analytical and organized approach.
Experience and ability in project management.
Demonstrated knowledge of BEC products (Hematology, Flow Cytometry, and Urinalysis).
Ability to drive results, foster teamwork, handle pressure, and provide feedback
Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.
Experience participating on cross functional teams.
PERSONAL SKILLS / ATTRIBUTES:
Able to work effectively in a collaborative team environment, across multiple functions.  Able to skillfully manage conflict and bring issues to timely resolution.
Excellent communication and interpersonal skills.  Strong leadership and multitasking abilities. Possess a unique blend of business and technical savvy, a big picture vision and excellent understanding of CAPA and QS activities.
Able to apply business understanding and technical expertise and full knowledge of other related disciplines to assist in solving complex technical and business issues; Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations.
Readily accepts responsibility and accountability for project success and key decisions.
Proven ability to work cross-functionally in a team based environment.
Proficient in MS Office Suite of products.
Willingness to be flexible and adaptable to changing priorities.
Excellent oral and written communication skills.
Effective analytical and problem solving skills.

Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.