Quality Assurance Specialist

4 weeks ago


South Bend, Indiana, United States Tri-Pac Inc Full time
Job Description

Tri-Pac, Inc. is a leading contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers. We are seeking an experienced Quality Document Control Specialist to join our fast-growing team.

Key Responsibilities:

  • Ensure the maintenance of document and record control systems to meet Quality Management System requirements.
  • Coordinate the issuance, revision, review, and approval of SOPs and other documents.
  • Monitor the status of in-process document changes to ensure timely completion.
  • Review and release raw materials, intermediate products, and finished products.
  • Manage the approval and archival of SOPs, WI, Process Flows, CAPA, OOS, deviations, nonconformance, complaints, and investigation as required.
  • Support the establishment and improvement of quality systems and facilitate continuous improvements efforts of the Quality System.
  • Assist in quality audits, including document preparation and record retrieval.

Requirements:

  • BA, BS Degree in Business.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, and Outlook), Adobe Acrobat, and SAP.
  • Five years' experience in GMP environment with relevant Quality Assurance/Compliance experience.
  • Knowledge of FDA 210, 211, and ISO 13485, 9001, 22716 preferred.

Benefits:

  • Competitive Salary/Pay & Packages.
  • Vacations.
  • Insurance.
  • 401K.
  • Life Insurance.
  • Disability (Long term/Short term).
  • Continuous Training.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer.



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