CAPA Process Analyst II

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Deb Chatterjee at email address

Deb.Chatterjee@generistek.com

We have Contract role CAPA Process Analyst for our client at Gretna, LA.Please let me know if you or any of your friends would be interested in this position.

Position Details:

CAPA Process Analyst - Gretna, LA

Location                         : Gretna, LA 70053

Project Duration        : 6+ months

Payrate                           : $30/hour on W2

Screening Questions:

·         Do you have hands-on experience with the CAPA (Corrective and Preventive Action) process? If yes, how many years?

·         Have you worked in a regulated environment (pharma, medical device, or laboratory)?

·         Do you have experience conducting root cause analysis (RCA)? Which methods have you used?

Description:

• Years Experience: 4+ Years
• The CAPA Process Analyst II:
  • Conducts investigations of nonconformances/quality events and progresses the associated quality records through Abbott’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 Abbott 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

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

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Deb Chatterjee at email address

Deb.Chatterjee@generistek.com

About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.