Quality Assurance Technician

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Overview:
Business Title: Quality Assurance
Position Title: Quality Assurance Technician
Division: Consumer Products Services 
Entity: ATL
Location: Landis, NC
Reports to: ATL Manager
FLSA: [Non-exempt/Exempt]
 
Hours Worked: Typically, Monday through Thursday 
Must be flexible to meet business needs or cover shifts a requested
2 shifts, Mon-Fri 8-hour, and Fri-Mon 10-hour
•    Tasks may require executing activities which require wearing appropriate PPE.
•    Manufacturing is a 24 hour/day operation, off-hour support may be required.

Position Summary:
The Quality Assurance Technician provides support to Regional Third-Party Logistics and Warehousing, based out of Salisbury, NC. The QA Technician will 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. Persons must be able to lift items up to 50 pounds. The QA Technician’s position is essential for maintaining quality systems and ensuring GMP compliance
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.
•    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.)
•    Work closely with site customers to report and resolve issues and improve the process.
•    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.
•    Data Management & Archives
o    Managing company archives and fulfills client requests for raw data copies
o    Enter data into databases and maintain data integrity
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

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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
•    Statistical Analysis & Metrics
o    Perform statistical analysis supporting training, QC acceptance limits, method validations, quality incidents, raw data inspections, and deviations
o    Conduct proficiency testing per the Proficiency Test Plan
o    Collect and compile QC data from raw data for analysis
o    Develop and present KPI status reports as needed
o    Support management reporting on quality and productivity metrics
•    CAPA & Vendor Management
o    Respond to external audit reports following CAPA approval
o    Issue CAPAs as required and validate CAPA records as assigned
o    Maintain the Approved Vendor List and distribute supplier surveys
•    Advanced Audit Activities
o    Plan, execute, and document internal audits
o    Support formal audit activities
o    Assessing GMP status of analytical equipment
o    Substitute for Quality I-II functions when needed

Skills & Proficiencies:
•    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.)

Education and Experience:
•    Associates Degree preferred / HSD accepted with experience
•    Minimum of 5 year(s) of experience in warehouse, logistics GMP environment 

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

Compensation Range: $26 - $34 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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