Sign upLog in

CAPA Process Analyst II

Lancesoft

Gretna, LA

Apply
JOB DETAILS
SALARY
$28.57
LOCATION
Gretna, LA
POSTED
30+ days ago
Title: CAPA Process Analyst II:
Location: Gretna, LA 70053
Duration: 6 Months
  • Looking for experience with CAPA systems and assisting with helping to administer the process.
  • Must be able to use EQMS.

Description:
Years Experience: 4+ Years
  • Conducts investigations of nonconformances/quality events and progresses the associated quality records through Client 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 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

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

Resume Resources

Free Resume TemplatesFree Resume Builder