Quality Assurance Specialist

LocationShelbyville, Kentucky
DepartmentQuality Assurance
Reports ToQA Manager
Position Overview

The Quality Assurance Specialist role is responsible for supporting the proper completion of batch records as well as supporting the issuances of Certificates of Analysis, and reports to the Quality Assurance Manager.

Duties & Responsibilities
  • Review and verification of critical process steps on the Production floor. (reviewing equipment setup, raw materials, inspecting pre- and post-pack) and documenting on batch records, equipment logs and other controlled documents
  • Review of batch records, product files and quality control data, and Certificates of Analysis for the purposes of product release
  • Responsible for completeness of documentation such as batch record and QC data prior to product release
  • Review and release of raw materials and finished goods for shipment and stock through ERP systems
  • Support the Issuance of Certificates of Analysis
  • Contributing to any investigations and deviations associated with the product under review
  • Sufficient knowledge of manufacturing process.
  • Sufficient knowledge of customer base
  • Sufficient knowledge of applicable regulatory requirements
  • Effective communication throughout the organization – manufacturing, quality control, document management
  • Assistance to the Quality Assurance Manager in providing guidance and direction to all operational departments to ensure good quality practices
  • Other duties as assigned by the Quality Assurance Manager
  • Support and assist and CAPA investigations regarding manufacturing issues.
Skills & Qualifications
  • Background in an industrial, fast paced, chemical manufacturing environment preferred
  • Pharmaceutical/GMP experience a plus
  • Ability to observe, verify and document production activities such as confirmation of raw materials, lot numbers, expiration dates, line clearance, weights, simple calculations, etc.
  • Great attention to detail and good organizational skills
  • Effective interpersonal and communication skills.
  • Demonstrate commitment to safety, environmental practices, production targets, and quality standards
  • Self-motivated and forward-thinking individual who is able to self-direct workload and priorities, and acts to create efficiencies and resolve issues within their scope of responsibility.
  • Dedicated to business objectives and continuous improvement through adaptability, innovation, and agility
  • Possesses Company values of Honesty, Integrity, Respect and Commitment coupled with the ability to accept and drive change.