QA Logistics Operations Lead

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Business

Title:

Quality Assurance IV

Position Title:

QA Logistics Operations Lead
Division:
Consumer Products Services
Entity: ATL

Location:

Plainfield, IN

Reports to:

ATL Manager
FLSA:
Non-exempt
Hours Worked:
Typical shifts Monday – Friday is 7:30am – 4:15pm. However, must be flexible to meet business needs and work overtime required.
Must be flexible to cover different shifts with little notice (Monday – Thursday 7:30am - 4:15pm) or (Sunday – Thursday 11:15am - 8pm).

Position Summary:

The QA Logistics Operations Lead supports product distribution within the United States as well as exports to international affiliates and will serve as an expert for distribution release. This position is responsible for quality oversight and warehouse floor support for North America Logistics Operations in a pharmaceutical distribution environment and for export operations to international affiliates. This role is a point of contact between QA and Operations and is expected to make decisions regarding quality within the warehouse quality system.

The QA Logistics Operations Lead is responsible for ensuring compliance with all Good Manufacturing Practices (GMPs), internal standards, systems, procedures, and guidelines for distribution activities.

• Ensure products are delivered on time while fostering a team quality culture as the foundation of your work, and operate in safe and effective manner
• Timely and accurate disposition of shipments for release to markets
• Quality support for international, domestic, and for third party logistics warehouse (3PL) operations
• Presence on the warehouse floor to answer questions and provide assistance to operations.
• Provide coaching and feedback to operational staff reporting to this role
• Apply technical expertise regarding distribution to make independent decisions;
  Make decisions to impact timely completion of documentation (deviations, product complaints, distribution complaints, CARTS)
• Read and interpret wireless temperature monitor data for shipments
• Review/write procedures
• Collaborate with other functions, including hands-on work and shared learning experiences
• Collect complaint details and initiate complaint records
• Author and investigate minor deviations and CAPAs
• Lead team projects with quality and business functions, specifically to drive process improvements
• Ensure area is in a state of inspection readiness;
  Support local, global and regulatory inspections
• Ensure Data Integrity and Good Documentation Practices while performing job tasks
• Provide updates to management regarding the quality performance within areas of support;
  Maintain metrics and quality reporting
• Maintain GMP Library documentation
• Data Management & Archives
• Managing company archives and fulfills client requests for raw data copies
• Enter data into databases and maintain data integrity
• Organize, maintain, and consolidate data within established protocols
• Create reports and logbooks assigned
• Documentation & Records
• Maintain quality systems documentation, including procedures, forms, quality records, and external standards
• Organize, index, file, and store all quality systems documentation and quality records
• Receive, review, control, and track documents per established processes and procedures
• Create and control QA forms, issuing them as needed
• Operational Support
• Order supplies and maintenance items as needed
• Maintain site training and equipment records
• Support client and company initiatives by providing basic QA support activities
• Support client, safety, and regulatory body audits as assigned
• Follow Bureau Veritas policies and procedures
• Process Improvement
• Identify gaps in the document control process and provide process improvements
• Ensure the document control system remains compliant with current regulations
• Maintain quality systems in company operations
• Review & Approval Authority
• Conduct quality review and approval of method validations
• Assist in review and approve OOS and deviation investigations, ensuring proper change control/CAPA implementation.
• Review approved Certificates of Analysis and calibration records
• Review and approve instrument qualification and method…