Job Description

Global company is looking for a Plant Documentation Specialist. This is a long term temporary position that will last through the end of the year. Compensation is $25 per hour.

Hours:

  • 8:30am- 4:30pm
  • Monday- Friday

Responsibilities:

  • Implement Document Control programs that assure all documents related to the product quality meet the requirement of: - QS 035 - Documentation - FDA Good Manufacturing Practices (cGMP) - Local regulations requirements
  • Issue, maintain, control, and audit documentation for compliance as well as reviewing all production documentation
  • Maintain, control, and audit site documentation to ensure compliance These include:
    • Standard Operating Procedures and associated documents
    • Manufacturing Batch Production Records and associated documents
    • GMP Training Records
  • Create and maintain Standard Operating Procedures for the cGMP compliance programs
  • Develop and manage a document control system designed to achieve cGMP compliance
  • Develop and manage a file system for current and archived documents required for cGMP compliance
  • Manage libraries of SOPs, Formulas, Manufacturing SOPs, Lab SPIs, and general SOPs to ensure accuracy and reliability
  • Audit all documentation required to support the business
  • Review all production documentation for GMP and accuracy in support of product release
  • Assure cGMP documentation training to new employees and as a part of annual training
  • Participate in internal and external audits as part of the Plant GMP and Quality Team

Qualifications:

  • Associates degree in a science related field
  • 1 year of industrial experience in FDA regulated consumer products, pharmaceutical or Food industries. This experience should include working in a quality system environment with exposure to governmental audits and assessments
  • Excellent interpersonal and communication skills
  • Able to communicate information clearly, simply and in a timely manner
  • Strong multitasking skills and time management skills
  • Microsoft Office Suite proficiency

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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