The DOCUMENT SPECIALIST will help support the document creation and review for testing needs for our North American clients. This individual will create Re-Qualification test protocols and templates reports, review the executed Re-qualification test reports as well as support the field service team when required with documentation questions but also help to develop and improve qualification documents and strategies. The employee will act as a global technical resource for documentation-related tasks including, but not limited to, client technical support, technical process innovation, test method development, training.
- Bachelor’s degree in mechanical engineering, pharmaceutical technology, chemical engineering or Experienced technician: experience in GMP/technical environment or equivalent experience
- 1-2 years of 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 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
- Fluent in English. German language fluency is a plus
- Must be able to lift over 35 lbs