QA Logistics Operations Lead

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Overview:

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

Duties and Responsibilities:

It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.

• 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

o Managing company archives and fulfills client requests for raw data copies

o Enter data into databases and maintain data integrity

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o Organize, maintain, and consolidate data within established protocols

o Create reports and logbooks assigned

• Documentation & Records

o Maintain quality systems documentation, including procedures, forms, quality records, and external standards

o Organize, index, file, and store all quality systems documentation and quality records

o Receive, review, control, and track documents per established processes and procedures

o Create and control QA forms, issuing them as needed

• Operational Support

o Order supplies and maintenance items as needed

o Maintain site training and equipment records

o Support client and company initiatives by providing basic QA support activities

o Support client, safety, and regulatory body audits as assigned

o Follow Bureau Veritas policies and procedures

• Process Improvement

o Identify gaps in the document control process and provide process improvements

o Ensure the document control system remains compliant with current regulations

o Maintain quality systems in company operations

• Review & Approval Authority

o Conduct quality review and approval of method validations

o Assist in review and approve OOS and deviation investigations, ensuring proper change control/CAPA implementation.

o Review approved Certificates of Analysis and calibration records

o Review and approve instrument qualification and method validation documents

o Manage the inspection and approval of laboratory data prior to release

• System Development & Management

o Develop, maintain, and enhance quality systems in company operations

o Develop and implement quality and document control system procedures

o Lead quality event tracking and trending activities

o Manage internal audit scheduling and task assignments for trained QA personnel

• Vendor & Equipment Management

o Evaluate and approve supplier surveys for laboratory vendor qualification

o Manage site laboratory equipment vendors providing repair, calibration, or preventive maintenance services

o Maintain site Training and Equipment Tracking Matrices

o Ensure site training and equipment systems are in an audit-ready state

• Cross-Functional Leadership

o Facilitate review and revision of procedures, specifications, and forms with functional departments

o Participate in formal audit activities

o Substitute for Quality I-III functions as necessary

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Skills & Proficiencies:

• 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

Education and Experience:

• 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

An equivalent combination of education and experience may be accepted in lieu of above.

Compensation Range: $25.50 - $28.00 an hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).

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