Job Title: CAPA Process Analyst II
Location: Gretna, LA 70053 (Onsite)
Duration: 6-month contract (possible extension)
Employment Type: Contract (W2 / 1099)
Job Summary:
The CAPA Process Analyst II is responsible for leading and supporting investigations related to nonconformances and quality events within a regulated environment. This role focuses on managing CAPA activities, ensuring compliance with QMS procedures, and maintaining audit-ready documentation using EQMS platforms. The analyst will collaborate with cross-functional teams to drive effective root cause analysis and corrective actions aligned with regulatory standards.
Responsibilities:
- Lead investigations of nonconformances, deviations, and complaints within the CAPA system
- Execute and manage CAPA activities in compliance with established QMS procedures
- Perform root cause analysis and ensure appropriate corrective and preventive actions are implemented
- Maintain accurate and audit-ready CAPA documentation within EQMS systems
- Collaborate with laboratory operations and technical teams to support investigations
- Ensure timely closure of quality records and adherence to regulatory requirements
- Identify trends and support continuous improvement initiatives
- Escalate compliance risks and quality concerns to Quality Management
- Communicate effectively across cross-functional teams
- Prioritize workload based on business needs and project timelines
- Support internal and external quality audits
- Perform additional duties as assigned by the Quality Manager
Required Qualifications:
- Bachelorโs degree in Life Sciences or related field
- Experience in CAPA processes within regulated environments (pharma, medical devices, or labs)
- Hands-on experience with QMS platforms and EQMS systems
- Strong technical writing and communication skills
Preferred Qualifications:
- ASQ Certified Quality Auditor (CQA)
- Project management experience
- Knowledge of CAP, NLCP, FDA, or similar regulatory standards
- Experience working in Agile environments
Salary: The hourly rate for this position is $29 โ $32 per hour. Compensation is based on experience, skills, and qualifications.
Benefits: This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer: We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check: Background checks may be conducted in accordance with applicable law.
Work Authorization: Applicants must be authorized to work in the United States.