QA Logistics Operations Lead

Bureau Veritas•Plainfield, NJ

3d•$26 - $28•Onsite

About The Position

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

Requirements

Written and verbal communication skills include the ability to communicate effectively in a group setting, with colleagues and clients
Organizational and time management skills
Ability to perform multiple tasks
Ability to organize and prioritize workload to meet or exceed deadlines
Individual and Team work ethic
Proficiency with Windows, Word & Excel
Positive attitude, self-motivated, high level of engagement
Demonstrated expertise in developing, maintaining, and improving quality systems
Ability to lead quality issues and implementing corrective actions
Excellent problem-solving and critical thinking abilities to identify and resolve complex quality challenges
Thorough understanding of relevant regulations, industry standards, and best practices
Proven learning agility
Skills include ability to prioritize, work independently, written and oral communication, cross-functional collaboration, fundamental knowledge of computer applications, and problem solving.
Proven ability to collaborate with globally diverse groups
Excellent organizational skills to organize / prioritize individual and team workload to meet or exceed deadlines
Ability to juggle multiple tasks and changing priorities in a very busy environment
Attention to detail
Champions company values
High School Degree; additional education preferred
Minimum of 4 year(s) of experience within a GMP, Distribution Warehouse environment, SAP Exacta Warehouse Management system (SAP/S4P/Exacta systems), handle held RF devices, pallet jacks and a variety of powered industrial trucks.
Direct experience in pharmaceutical logistics, cGMP compliance, and FDA-regulated distribution operations required.
Experience working with cold chain processes and quality operations support
Experience with Lean methodology and systems approach

Responsibilities

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
Managing company archives and fulfills client requests for raw data copies
Enter data into databases and maintain data integrity-o Organize, maintain, and consolidate data within established protocols
Create reports and logbooks assigned
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
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
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
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 validation documents
Manage the inspection and approval of laboratory data prior to release
Develop, maintain, and enhance quality systems in company operations
Develop and implement quality and document control system procedures
Lead quality event tracking and trending activities
Manage internal audit scheduling and task assignments for trained QA personnel
Evaluate and approve supplier surveys for laboratory vendor qualification
Manage site laboratory equipment vendors providing repair, calibration, or preventive maintenance services
Maintain site Training and Equipment Tracking Matrices
Ensure site training and equipment systems are in an audit-ready state
Facilitate review and revision of procedures, specifications, and forms with functional departments
Participate in formal audit activities
Substitute for Quality I-III functions as necessary