Quality Assurance Associate

Bureau Veritas•Landis, NC

1d•$28 - $34

About The Position

The QA Associate provides support to Third-Party Logistics and Warehousing, across the US (travel 20-30% of time). The QA Representative provides oversight of operations and directly manages quality functions, guidance to incoming material technicians and will advise on issues such as non-conformance investigations, change control proposals, procedures, commissioning, and qualification activities. This position will also support activities within Warehouse operations, including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections of materials and sampling of items (components, printed packaging materials, etc.) utilizing SAP and LIMS. The QA Associate position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.

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
Attention to detail
Positive attitude, self-motivated, high level of engagement
Demonstrated expertise in developing, maintaining, and improving quality systems
Advanced technical skills in method validation, equipment qualification, and data review
Ability to lead cross-functional teams in addressing quality issues and implementing corrective actions
Strong project management skills to coordinate quality initiatives across the organization
Excellent problem-solving and critical thinking abilities to identify and resolve complex quality challenges
Thorough understanding of relevant regulations, industry standards, and best practices
Bachelor’s Degree in logistics, manufacturing, quality assurance or closely related field
Minimum of 5 year(s) of experience with GMP, warehouse or manufacturing environment
An equivalent combination of education and experience may be accepted in lieu of above.

Responsibilities

Provide direct quality oversight of third-party operations.
Oversee third-party operations across the US, traveling as necessary for on-site support, inspections, and oversight.
Author, review and approve documents including, but not limited to, procedures, change control proposals, deviations, CARTS, and equipment qualifications.
Ensures all areas of oversight remain in quality compliance per SOPs and cGMP requirements.
Provide quality guidance and recommendations regarding materials, utilities, and maintenance.
Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
Participate in aberrant data investigations.
Provide coaching, feedback and mentoring to QA Technicians as it relates to execution of quality systems.
Work with Lilly support groups and external partners to resolve or provide advice on receiving or shipping issues.
Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
Evaluating temperature excursions on shipments received at the warehouse.
Identifies and assists in resolving issues on shipments (i.e. Incorrect quantity or product, contamination, etc.).
Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, Investigate customer complaints.)
Work closely with site customers to report and resolve issues and improve the process.
Participate in and/or support recalls, as appropriate.
Conduct gap assessments of global requirements and ensure implementation of the governing standards.
Participate in and/or lead self-inspection activities.
Participate in and/or support regulatory inspections and audits.
Maintain and improve quality systems.
Assist others in the interpretation of regulatory and corporate requirements.
Data Management & Archiveso Managing company archives and fulfills client requests for raw data copieso Enter data into databases and maintain data integrityo Organize, maintain, and consolidate data within established protocolso Create reports and logbooks assigned
Documentation & Recordso Maintain quality systems documentation, including procedures, forms, quality records, and external standardso Organize, index, file, and store all quality systems documentation and quality recordso Receive, review, control, and track documents per established processes and procedureso Create and control QA forms, issuing them as needed
Operational Supporto Order supplies and maintenance items as neededo Maintain site training and equipment recordso Support client and company initiatives by providing basic QA support activitieso Support client, safety, and regulatory body audits as assignedo Follow Bureau Veritas policies and procedures
Process Improvemento Identify gaps in the document control process and provide process improvementso Ensure the document control system remains compliant with current regulationso Maintain quality systems in company operations
Review & Approval Authorityo Conduct quality review and approval of method validationso Assist in review and approve OOS and deviation investigations, ensuring proper change control/CAPA implementation.o Review approved Certificates of Analysis and calibration recordso Review and approve instrument qualification and method validation documentso Manage the inspection and approval of laboratory data prior to release
System Development & Managemento Develop, maintain, and enhance quality systems in company operationso Develop and implement quality and document control system procedureso Lead quality event tracking and trending activitieso Manage internal audit scheduling and task assignments for trained QA personnel
Vendor & Equipment Managemento Evaluate and approve supplier surveys for laboratory vendor qualificationo Manage site laboratory equipment vendors providing repair, calibration, or preventive maintenance serviceso Maintain site Training and Equipment Tracking Matriceso Ensure site training and equipment systems are in an audit-ready state
Cross-Functional Leadershipo Facilitate review and revision of procedures, specifications, and forms with functional departmentso Participate in formal audit activitieso Substitute for Quality I-III functions as necessary