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Masis Professional Group

Masis Professional Group is hiring: Technical Writer – Quality / Validation in B

Masis Professional Group, Bethlehem, PA, US, 18020

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🚨Technical Writer – Quality / Validation


🔁 Contract-to-Direct Opportunity

Local to Bethlehem, PA only

No C2C | No Sponsorship


Summary:

Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements.


Key Responsibilities:


  • Oversight of Validation and Qualifications
  • Oversight of Customer Complaints
  • Document Control Activities
  • Procedure Updates
  • Write and Executed Qualification Documents
  • Write Qualification Summary Reports
  • Procedure Updates


Required Skills & Experience:

  • Bachelor degree or higher in relevant scientific/quality assurance/technical field
  • Technical writing/documentation experience in pharma or regulated manufacturing
  • Experience with qualification and validation documentation
  • Solid understanding of cGMP
  • Excellent written communication and organizational skills
  • Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems