CAPA Process Analyst

Akkodis is seeking a CAPA Process Analyst II for an 8-month contract with a client in Gretna, LA 70053 (Onsite).

Title: CAPA Process Analyst II

Location: Gretna, LA 70053 (Onsite)

Duration: 8 months w/ possibility of extension

Pay Rate: $30-32/hr (The rate may be negotiable based on experience, education, geographic location, and other factors).

Shift: Fully on-site, 8 am to 5 pm

Job Description:

Years of Experience: 4 Years

The CAPA Process Analyst II:

• Conducts investigations of nonconformances/quality events and progresses the associated quality records through Client’s 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 Abbott 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

If you are interested in this job, please get in touch with Udbhav Mathur at udbhav.mathur@Akkodisgroup.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance