Documentation Specialist Max Salary $75K Doe

Key Requirements:

• Have a strong customer focus
• Have good written and verbal communication skills
• Previous laboratory, pharmaceutical knowledge preferred
• Must be outgoing, professional in appearance, and have the ability to interact and converse with both external customers and internal client Sales, Service, and Technical support personnel.
• Carry out the work in an accurate independent manner
• Bachelor’s degree in mechanical engineering, pharmaceutical technology, chemical engineering or Experienced technician: experience in GMP/technical environment or equivalent experience
• Knowledge and technical expertise related to H2O2 decontamination, cGMP Standards, OSHA requirements, FDA and EU guidance related to aseptic production, USP and EP standards are all very desirable.
• Ability to follow SOP’s, follow instructions, with attention to detail and final report generation.
• 1 – 2 year experience in GMP documentation and documentation creation, experience with calibration work.

Key Responsibilities:

• Develop and improve qualification documents and strategies develop and improve qualification documents and strategies
• Create and distribute accurate and detailed visit reports
• Communicate status updates with customers and clients
• Communicate with our client about documentation issues
• Support the field service team when required with documentation questions
• Provide backup training to technicians when errors are identified
• Create Re-Qualification test protocols and templates report.
• Review executed Re-qualification test reports and forward open punch items to person in charge.