Documentation Specialist

Qualifications

• Bachelor's degree in mechanical engineering, pharmaceutical technology, chemical engineering or Experienced technician: experience in GMP/technical environment or equivalent experience
• 1 - 2 year experience in GMP documentation and documentation creation, experience with calibration work.
• 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.
• Ability to follow SOP's, follow instructions, with attention to detail and final report generation.
• Have good written and verbal communication skills
• Have a strong customer focus
• Carry out the work in an accurate independent manner
• Previous laboratory, pharmaceutical knowledge preferred
• 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.
• Fluency with MS Office Suite products is required
• Must be able to lift over 35 lbs

Responsibilities

• Communicate with our client about documentation issues
• Create Re-Qualification test protocols and templates report.