You are viewing a preview of this job. Log in or register to view more details about this job.

QA Specialist I

QA Specialist I
Shift
The shift hours and days for this position are 4pm – 4am Thursday – Saturday, rotating Sunday (see below)
  • Thursday, Friday, Saturday – 3x12 shift (4pm to 4am)
  • Rotation – Every other Sunday (4pm to 4am)
Essential Functions:
  • Will provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site.
  • Direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address compliance issues and questions real time.
  • Ensures adherence to proper escalation when non-conformances are identified as outlined per applicable procedures. 
  • Serves as a resource for compliance, escalation and corrections.
  • Ensure departmental compliance to procedures, gmp records and associated forms.
  • Ensures documentation is recorded in accordance with ALCOA principles.
  • Work with operating entities with guidance from senior colleagues to ensure that inspections, statistical processes control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. 
  • May assist with investigations and corrective and preventive actions (CAPA).   
Knowledge, Experience & Skills:
  • 2+ years of relevant experience in a GMP environment related field and a BS.  OR 3+ years of relevant experience and an AA degree.
  • Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates basic knowledge of FDA standards and quality systems. 
  • Demonstrates good verbal, written, and interpersonal communication skills. 
  • Demonstrates working knowledge in Microsoft Office applications. 
  • Demonstrates basic knowledge of FDA standards and quality systems. 
  • Biopharmaceutical or Pharmaceutical experience preferred. 
Shift
  • Thursday, Friday, Saturday – 3x12 shift (4pm to 4am)
  • Rotation – Every other Sunday (4pm to 4am)