Job Description
Title: CAPA Process Analyst II:
Location: Gretna, LA 70053
Duration: likely be somewhere between 6-12 months.
Description:
Years Experience: 4+ Years
Main Responsibilities:
Required Qualifications:
Preferred Qualifications:
Location: Gretna, LA 70053
Duration: likely be somewhere between 6-12 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
Numbers & Facts
| Location | Gretna, LA |
| Industry | Staffing/Employment Agencies |
| Salary | $30–$33.41 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
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.
Skills
- Agile Programming Methodologiesunmatched
- American Society for Quality (ASQ)unmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Laboratoryunmatched
- Communication Skillsunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Documentationunmatched
- Establish Prioritiesunmatched
- External Auditunmatched
- FDA (Food and Drug Administration)unmatched
- Information Technology/Systems Auditunmatched
- Internal Auditunmatched
- Interpersonal Skillsunmatched
- Laboratory Operationsunmatched
- Medical Equipmentunmatched
- Pathologyunmatched
- Presentation/Verbal Skillsunmatched
- Procedure Developmentunmatched
- Process Analysisunmatched
- Project/Program Managementunmatched
- Quality Managementunmatched
- Quality System Requirements (QSR)unmatched
- Record Keepingunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Root Cause Analysisunmatched
- Systems Maintenanceunmatched
- Technical Operationsunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Trend Analysisunmatched
- Writing Skillsunmatched
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