Bureau Veritas Group

Quality Assurance Technician

Bureau Veritas Group

full-time

Posted on:

Location Type: Office

Location: Landis • North Carolina • United States

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Salary

💰 $26 - $34 per hour

About the role

  • Performs sampling activities per GMP sampling plans
  • Ensures all areas of work remain in quality compliance per SOPs and cGMP requirements.
  • Author and submit complaints to suppliers (CARTS) and intra-company issues (ICIs)
  • Provide quality guidance and recommendations regarding materials, utilities, and maintenance.
  • Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
  • Identifies and assists in resolving issues on shipments (i.e. Incorrect quantity or product, contamination, etc.).
  • Work closely with site customers to report and resolve issues and improve the process.
  • Practices safety behaviors with proper PPE and lifting techniques.
  • Participate in aberrant data investigations.
  • Work with Lilly support groups and external partners to resolve or provide advice on receiving or shipping issues.
  • Review TempTale data, input SAP TOR reports from the data and escalate any abnormalities
  • Participate in and/or support recalls/rejections/returns, as appropriate.
  • Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, Investigate customer complaints.)
  • Conduct gap assessments of global requirements and ensure implementation of the governing standards.
  • Participate in self-inspection activities and support regulatory inspections/audits.
  • Maintain and improve quality systems.
  • Execute, review, and maintain GMP documentation generated during logistics operations. Manage the GMP library.
  • 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
  • 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
  • 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
  • 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
  • Perform statistical analysis supporting training, QC acceptance limits, method validations, quality incidents, raw data inspections, and deviations
  • Conduct proficiency testing per the Proficiency Test Plan
  • Collect and compile QC data from raw data for analysis
  • Develop and present KPI status reports as needed
  • Support management reporting on quality and productivity metrics
  • Respond to external audit reports following CAPA approval
  • Issue CAPAs as required and validate CAPA records as assigned
  • Maintain the Approved Vendor List and distribute supplier surveys
  • Plan, execute, and document internal audits
  • Support formal audit activities
  • Assessing GMP status of analytical equipment
  • Substitute for Quality I-II functions when needed

Requirements

  • Associates Degree preferred / HSD accepted with experience
  • Minimum of 5 year(s) of experience in warehouse, logistics GMP environment
  • Demonstrated strong written and verbal communications skills.
  • Strong attention to detail.
  • Advanced data analysis and reporting skills
  • Proficiency in conducting internal audits independently
  • Ability to issue CAPAs and manage corrective/preventive actions
  • Expertise in GMP, and regulatory compliance
  • Strong vendor management and supplier quality assurance skills
  • Ability to review and understand quality management system requirements. Proficient in using quality management software and databases
  • 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
  • Proficiency with computer system applications.
  • Knowledge of cGMPs and quality systems.
  • Excellent interpersonal skills and networking skills.
  • Ability to organize and prioritize multiple tasks.
  • Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.
  • Experience in inventory management systems (EWM, SAP, etc.)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPdata analysisinternal auditsCAPA managementquality management systemstatistical analysisproficiency testingdocument controlquality assuranceinventory management
Soft Skills
written communicationverbal communicationattention to detailorganizational skillstime managementteamworkself-motivationpositive attitudeinterpersonal skillsability to multitask