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CAPA Process Analyst II

Generis Tek Inc.

Gretna, LA

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JOB DETAILS
SALARY
SKILLS
Agile Programming Methodologies, American Society for Quality (ASQ), Biology, Biotech and Pharmaceutical, Clinical Laboratory, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Documentation, Establish Priorities, External Audit, FDA (Food and Drug Administration), Fortune 500 Customers, Information Technology/Systems Audit, Internal Audit, Interpersonal Skills, Laboratory, Laboratory Operations, Medical Equipment, Pathology, Philosophy, Presentation/Verbal Skills, Procedure Development, Process Analysis, Project/Program Management, Quality Management, Quality System Requirements (QSR), Record Keeping, Regulations, Regulatory Requirements, Root Cause Analysis, Systems Maintenance, Technical Operations, Technical Writing, Time Management, Toxicology, Trend Analysis, Writing Skills
LOCATION
Gretna, LA
POSTED
1 day ago
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Priyanka Mahant at email address  Priyanka.mahant

himanshi.pandit@generistek.com

can be reached on # (630) 576-1940.
 
We have Contract role CAPA Process Analyst for 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      : 6-12 Months of contract
Pay Rate                       : $32.00 per hour on W2
 
Job Description:
  • Looking for experience with CAPA systems and assisting with helping to administer the process. Must be able to use EQMS.
  • 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 Client 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 Client 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
 
Years Experience:
  • 4+ Years
 
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 Priyanka Mahant at email address  Priyanka.mahant

himanshi.pandit@generistek.com

can be reached on # (630) 576-1940.
 
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.
 

About the Company

G

Generis Tek Inc.

With over 15 years of experience servicing Fortune 500 customers across the globe, Generis Tek is consistently regarded as a pioneer in the IT and Professional Staffing and Services Industry. Finding the right talent for the job is a tough task, but it’s one we do especially well.
Generís Tek offers wide scope of services from strategizing to implementing that addresses these unique workforce challenges. Our professionals quickly adapt to clients work culture and become a core part of their team. We hire professionals as well as fresh grads from various disciplines to meet our client’s demands. Our focus is to create and manage a seamless stream of resources for a diverse, global, and effective talent pool. Working closely with our clients has enabled them to achieve their strategic objectives, leverage technological innovation and be cost effective.
We are driven by three core principles in changing Staff Augmentation for the better: cost, quality, and responsiveness. 
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2015
WEBSITE
http://www.generistek.com