What are the responsibilities and job description for the Documentation Specialist position at AllSTEM Connections?
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
- Fluent in English. German language fluency is a plus
- Must be able to lift over 35 lbs
Responsibilities
- Communicate with our client about documentation issues
- Create Re-Qualification test protocols and templates report.
- Review executed Re-qualification test reports and forward open punch items to person in charge.
- Support the field service team when required with documentation questions
- Create and distribute accurate and detailed visit reports
- Develop and improve qualification documents and strategies develop and improve qualification documents and strategies
- Communicate status updates with customers and clients
- Provide backup training to technicians when errors are identified
