Document Control Associate II

Quality Santa Cruz, California


Description

The Document Control Associate II ensures consistency, accuracy and regulatory compliance of product and documentation changes executed through the documentation processes. This position coordinates activities related to the approval and availability of Revision controlled documents, including but not limited to: SOPs, WIs, Finished Product Specifications, Raw Material & Packaging Specification, and Master Manufacturing Records. Additionally, the Document Control Associate II contributes to a variety of ongoing efforts related to relevant process streamlining and improvement.

 

Duties and Responsibilities

  • Review and verify new or changed documents/specifications and processes to ensure compliance prior to final approval.
  • Collaborate cross-functionally (e.g. Account Managers, R&D, Supply Chain, QC, Regulatory) to gather information and provide feedback on issues related to all product documentation.
  • Perform document audits of all new or changed controlled documents.
  • Generate customer change notification letters and track to completion.
  • Ensure continuous certification with ISO, FSSC, FDA, CFIA and other regulations as directed.
  • Understand and follow document Good Manufacturing Practices (GMPs) requirements with a focus on Change Control.
  • Contribute to ongoing process improvements with focus on document accuracy, efficiency and regulatory risk mitigation.
  • Support all departments with corrective actions, audit findings and follow-up.
  • Participate in various teams, including internal audit, sensory, GMP or others as required.
  • Provide regular reports as directed.

 

Required Qualifications

  • High School Diploma or equivalent.
  • 2 years’ professional Quality or change control experience.
  • Proficiency in Microsoft Office including Excel, Word and Outlook.
  • Strong organizational, follow-up, collaboration, accuracy, analysis, communication, writing and analytical skills.

 

Preferred Qualifications

  • Degree in business, science, engineering or related field.
  • Prior manufacturing, GMP, consumer packaged goods, pharmaceutical and/or nutraceutical industry experience.
  • Bilingual in English/Spanish.

 

Physical Requirements

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.