Open app
Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

CAPA Process Analyst II

TechLink+

Gretna, LA
Job Title: CAPA Process Analyst II
Location (On-site, Remote, or Hybrid?): Gretna, LA (onsite)
Contract Duration: Contract until 11/10/2026
Working hours: 8:00 - 5:00
Total hours: 40

Description:
Years Experience: 4+ Years



The CAPA Process Analyst II:

  • Conducts investigations of nonconformances/quality events and progresses the associated quality records through QMS platform in accordance with established procedures.
  • Collaborates with cross-functional teams to support investigations and ensure corrective actions are appropriate.
  • Ensures that corrective and preventive actions are appropriate, accurately and completely documented, implemented on time, and meet the required procedural and regulatory standards.
  • Interacts cross-functionally, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Code of Conduct.
Main Responsibilities:
  • Leads the investigation of complex and highly technical quality issues and ensures the timely completion of CAPA system activities initiated to address nonconformances, potential nonconformances, deviations, and/or complaints.
  • Executes investigations and CAPAs in accordance with established procedures, ensuring consistency with quality system requirements.
  • Serves as a subject matter expert in conducting investigations and performing root cause analysis to ensure that root and potential causes are appropriately identified and mitigated/eliminated.
  • Collaborates with laboratory operations and technical staff to conduct investigations and ensure corrective actions are appropriate and effectively implemented.
  • Maintains CAPA system records to ensure audit-readiness for internal and external quality system audits.
  • Ensure CAPA documentation is accurate, well-structured, and compliant with procedural requirements and regulatory guidelines.
  • Supports the initiation and implementation of improvement activities associated with identified trends.
  • Escalates potential compliance risks, quality concerns, or procedural gaps to the Quality Manager to ensure timely evaluation and resolution.
  • Demonstrates effective written and verbal communication skills.
  • Prioritizes workload in relation to business needs.
  • Supports the attainment of Toxicology Laboratories' goals and objectives.
  • Performs other duties as assigned by the Quality Manager.
Required Qualifications:
  • Bachelor's degree in Life Sciences
  • Experience with Corrective and Preventative Action process in regulated environments, pharmaceuticals medical devices or laboratories
  • Excellent communication and technical writing skills
  • Experienced in working with QMS platforms
Preferred Qualifications:
  • ASQ CQA
  • Project management experience
  • Knowledge of College of American Pathologists (CAP) regulations, NLCP regulations, or similar regulations (i.e., FDA).
  • Experienced in navigating Agile
Apply
Vacancy posted more than 2 months ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to CAPA Process Analyst II. Be the first to apply!

Related searches