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QA Lead Coordinator - PNO, TX

Lancesoft

Port Neches, TX

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JOB DETAILS
SALARY
$71.79
SKILLS
Auditing, Benchmarking, Best Practices, Billing, Biotech and Pharmaceutical, Budget Management, Business Strategy, Capital Expenditure (CAPEX), Continuous Improvement, Corrective Action, Document Management, Equipment Validation, Establish Priorities, External Audit, FDA (Food and Drug Administration), Failure Analysis, Failure Mode and Effects Analysis (FMEA), Finance, Follow Through, Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), ISO 14001, ISO 9001, Internal Audit, Lead Management, Leadership, Maintain Compliance, Needs Assessment, Onboarding, Organizational Skills, Performance Metrics, Process Improvement, Process Management, Procurement Management, Product Management, Product Safety, Product/Service Launch, Program Planning, Project Development, Quality Assurance, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Risk, Risk Analysis, Root Cause Analysis, Safety Systems, Safety Training, Sales, Schedule Development, Standard Operating Procedures (SOP), Status Reports, System Validation, Systems Administration/Management, Training/Teaching, Validation Plan, Vendor/Supplier Evaluation, Vendor/Supplier Quality Management
LOCATION
Port Neches, TX
POSTED
9 days ago
 Role                                           : QA Lead Coordinator
Location                                    : PNO, TX Port Neches, TX
Duration                                  :  06 Months 
Pay Range                              : $51.27/hr. On W2
 




Description: The Quality Assurance (QA) Lead Coordinator ensures the establishment, implementation, and maintenance of the Quality Management System (QMS) through audits, aiming for compliance and continuous improvement of the Quality and Food Safety System. This role promotes preventive actions to meet regulatory standards (HACCP, GMPs, ISO 9001, EFFCI, among others) and monitors non-conformances arising from various sources, ensuring products and processes are in line 

Prioritized Essential Job Functions and Responsibilities

ROLE
•Quality and Safety Management System Manager
•Product Safety Committee Leader
•Leader of the Product Safety Committees of all units for validation issues
•Internal Auditor

AUTHORITY
•Manage the execution of the Validation Master Plan.
•Make changes to Validation plans and programs.
•Manage the updating and generation of procedures and protocols for the validation of equipment, systems, and/or processes.
•Manage local Quality Management system.
•Product Safety Management.
•Authority to stop any product or service that puts at risk the quality, legality, or safety of the products, as well as any activity that puts at risk the physical integrity of people, the environment, and/or facilities.
•Determine the appropriateness and effectiveness of actions to close non-conformities.
RESPONSIBILITY
Quality Management and Compliance
•Define KPIs and their criteria with a continuous improvement approach and governance.
•Update and control the Document Management System.
•Promote, influence, and ensure compliance with the Quality and Safety Management System.
•Maintain current quality certifications, executing actions based on risk analysis, potential and real nonconformities, and seeking continuous improvement.
•Implement new quality certifications aligned with business strategy.
•Ensure that the quality and safety requirements of the products and production processes are met, adhering to standards and policies (ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC2200, EFfCI, Kosher, Halal, etc.).
•Implement GMP practices applicable to Quality Assurance.
•Develop initiatives and programs to promote quality standards.
•Develop and deliver training.
•Manage budget and process invoices.
•Support other functions in QA-related aspects or inquiries.
Program Development
•Lead local Quality & Product Safety Committees.
•Set up and lead management reviews.
•Coordinate recall, non-conformance, and food safety teams.
•Develop special projects assigned by top management such as mapping processes, SOPs, or implementing 5S programs.
FSSC and EXCiPACT
•Maintain the QMS/ FSMS to keep all quality and food certifications: FSSC 22000, ISO 9001: 2015, EFfCI, Kosher, Halal, and RSPO.
•Develop and monitor the annual internal and external audit program, including implementation.
•Pharma/ EXCiPACT expert –lead pharma certification projects.
Risk, Validation & Compliance
•Develop validation master plans.
•Develop cleaning and CCP (Critical Control Points) validations.
•Develop validation protocols.
•Continuously ensure compliance with validation programs and plans, as well as the evaluation of revalidation needs.
•Execute validations in accordance with the validation master plan and applicable protocols.
•Investigate system NCRs and root cause failure analysis.
Audit Responsibilities
•Develop and manage audit schedules.
•Coordinate internal and external audit scopes, objectives, and timelines.
•Assign internal and external auditors, ensuring appropriate expertise and availability.
•Maintain a qualified audit team and engage external consultants as needed.
•Oversee audit execution and compliance.
•Review and approve audit reports.
•Document and follow up through to closure on audit findings.
•Collaborate on action plans for audit findings, and
•Monitor trends and share insights from audit findings with leadership.
•Implement best practices in audit processes.
•Conduct internal audits and manage audit processes.
•Prepare audit result reports.
Tracking and Follow-Up
•Manage the follow-up of non-conformities and contribute to the preparation of root cause analyses.
•Ensure all audit findings are documented and followed through to closure.
•Monitor the quality metrics and report status to senior management.
•Develop and monitor the annual internal and external audit program, including implementation.
Regulatory Developments
•Maintain current quality certifications, executing actions based on risk analysis, potential and real nonconformities, seeking continuous improvement.
•Implement new quality certifications aligned with business strategy.
•Monitor the Foreign Supplier Verification Program-FDA.
•Assess legal requirements applicable to various sites.
Supplier Management
•Qualify and monitor suppliers, supporting supplier audits.
•Carry out and follow up on the supplier audits and internal audits program.
•Selection and monitoring of suppliers.
•Manage customer paperwork required for quality critical analysis (questionnaires, quality agreements, contracts, statements).
Continuous Improvement
•Define KPIs and their criteria with a continuous improvement approach and governance.
•Promote, influence, and ensure compliance with the Quality and Safety Management System.
•Develop initiatives and programs to promote quality standards.
•Implement and train risk analysis: FMEA & HACCP.
•Promote continuous improvement for quality processes based on external benchmarking.
Additional Responsibilities
•Update and control the Document Management System.
•Conduct quality onboarding for new employees.
•Investigate and respond to customer complaints and non-conformances.
•Provide feedback and approval during the new product introduction process.
•Manage budget and process invoices.
•Support other functions in QA-related aspects or inquiries.
•Perform and support other activities at other facilities/locations as requested by the direct supervisor.

Custom Fields:
Name: Hardware
Value: Laptop

Name: O365 Email
Value: Yes

Name: S4 Access
Value: No

Name: Software (Enter additional software as needed, ie: Aspen, or enter Not Applicable)
Value: n/a

Name: Departmental/Shared Folders Access (Enter path to folders, or enter Not Applicable)
Value: N/A

Name: S4 User Name to Mirror (Enter person's Name, or enter Not Applicable)
Value: Jorge Marte Castro

Name: Workstream Access, list all that are required (i.E., EHS, Finance, Plant Maintenance, Project Systems (capex), Operations, Sales, Procurement, Quality Management, Supply, or Not Applicable)
Value: Same as Jorge Marte Castro

Name: Citrix
Value: Yes

Name: VPN
Value: Yes
 

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/

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