Quality Assurance Associate I

Job description

Job description

Document control including but not limited to:

Formatting of documents, publishing, completing change control process

Document upload into training system and course creation

Annual document review including generation of list of documents due, issuing and tracking completion, document revision

Issue batch record documents

Scanning and filing of GMP records

Metrics- tracks and trends QA Quality Management System metrics

Reviews and provides input for Quality Management system elements including investigations and root cause analysis

Batch record review process: assembles and reviews all manufacturing and QCL related documents and data

Supports Internal and Client Audits

Supports Supplier Qualification activities

Perform shipping verifications as needed

Requirements

Position Requirements

  • Attention to detail and ability to consistently follow procedures
  • Strong organizational skills and ability to manage multiple tasks at one time
  • Demonstrated ability to work as both a team player and independently
  • Excellent verbal and written communication skills; excellent interpersonal skills at all levels
  • Desirable: knowledge of and ability to confirm compliance to US and EU GMP, USP, and Integrity Bio requirements
  • Validation knowledge desired: software, equipment, analytical method, system Validation protocol creation, execution, and approval: Software (SQL database, Moodle platform, MS Excel, etc.), equipment, systems (facilities, etc.)
  • Proficiency in MS Office
  • Flexibility to travel as required for business needs (up to 10%).
  • Physical Requirements
  • Subject to extended periods of sitting and/or standing in an office environment
  • Ability to lift 30 pounds 

Education and Professional Experience

Bachelor’s degree or minimum 1 year experience in GMP industry