Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Some similar recruitments
Settlement Coordinator Jobs
Recruited by SoFi 10 months ago Address Claymont, DE, United States

Capa Coordinator Jobs

Company

Advanced Clinical

Address Kent County, DE, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research
Expires 2023-07-04
Posted at 9 months ago
Job Description
Overview


  • This is a remote position that be worked from home anywhere in the United States or Europe***


This position is responsible for the daily administration and maintenance of Advanced Clinical’s Noncompliance and CAPA Management process and Quality Management System (QMS) software application. This position will work independently with direction from the Manager, Compliance and Quality in the Compliance and Quality department. This position will provide guidance and support to staff involved in the Noncompliance and CAPA management process and workflow to include technical consultation, tracking, and follow-up with staff to ensure organizational compliance with stated activities and due dates.


Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.


Responsibilities


  • Lead the Noncompliances and CAPAs through the QMS workflow
  • For ongoing periodic review, data inquiries, and status updates
  • Responsible for leading Root Cause Analysis, corrective and preventative action (CAPA)
  • Ensure that investigation/CAPA documentation is compliant with GxP, industry
  • Work with SMEs to develop appropriate effectiveness checks, as applicable
  • Perform other duties as assigned
  • Monitors and analyzes CAPA metrics and program trend analysis
  • Ensure investigations are approved by correct personnel and departments in a timely manner
  • Provide support in regular metrics reporting for Noncompliances and CAPAs
  • Provide training on the Noncompliance, CAPA and effectiveness check process/requirements to company staff
  • Lead the overall administration, tracking and management of Noncompliances and CAPAs at Advanced Clinical
  • Standards, company policy/procedure requirements.
  • Support subject matter experts (SMEs in conducting root cause analysis and developing CAPA plans using common industry techniques
  • Review Noncompliances to determine if an investigation or CAPA is necessary and recommends effectiveness plans.
  • Provide support to Compliance and Quality Management and Operations Quality teams


Qualifications


  • Must be able to work independently, manage multiple tasks, and meet defined deadlines.
  • Experience: Have previous experience working in an electronic Quality Management System such as Veeva Vault; Previous experience working in organizations regulated by Good Clinical Practices (GCPs); minimum 2 years performing quality tasks, to include noncompliance and CAPA activities
  • Establishes effective relationships with customers to understand and meet their needs.
  • Education: Bachelor’s or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is preferred or equivalent years of experience
  • Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
  • Strong oral and written communication skills with the ability to create concise technical documentation.
  • Must be a team collaborator, have exceptional organizational and time management skills, and be proficient with applicable software systems.
  • Training: Applicable quality assurance, regulatory, or clinical research-related training preferred
  • Ensures customer service standards are met.
  • Questions currently accepted ways of doing things. Generates alternatives before settling on a solution.


At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.


Equal Employment Opportunity


It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.


This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.