|Reference # :||20-05707||Title :||Technical Writer I|
|Location :||Pomona, CA|
|Experience Level :||Start Date / End Date :||06/01/2020 / 05/31/2021|
|Summary: The Technical Writer is part of the Tox business unit and is located at the Immunalysis site in Pomona, CA. The main function of the position is to create high quality documentation that is appropriate for its intended audience. This person should be able to create technical documents and manuals, explain complex information in a clear and concise manner and working with scientific staff to ensure accuracy of product description.|
? Directly participate in a Quality Systems Remediation Program, with the primary responsibility being the creation of high-quality written content.
? Daily Interaction with technical documentation, with documentation tasks to be performed with quantitated high-throughput and attention to detail.
? Required to proofread, prepare, create, review, edit, and update Quality and Technical Documents including, but not limited to: SOPs, work/testing instructions, Validation Documentation (IQ / OQ / PQ), Technical Reports, & Record Assessment Reports.
? Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
? Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.
? Learn complex concepts and communicate the information in a way that is engaging and understood by users.
? Mange and update revision to technical literature.
? Maintain a comprehensive library of technical terminology and documentation
? Carries out duties in compliance with established business policies.
? Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly.
? Perform other duties & projects as assigned.
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
? Bachelor's degree from an accredited university.
? Proven experience in technical writing position.
? Minimum of 3 years of technical writing experience in a GMP/Biotech/Pharma/Regulated Industry
? Demonstrated success in Technical Writing in the GMP / Biotech / Pharma / Medical Device/Regulated Industry
? Very strong written and verbal communication skills
? Strong experience owning and end-to-end documentation creating process
? Strong skills in Microsoft Office, especially in Word, Excel and PowerPoint
? General knowledge of Quality/Regulatory requirements in a medical device/ pharma/ biotech industry
? Very strong attention to detail
? Must be coach-able and must follow written and verbal direction
? Must be able to productively generate quality documentation to meet program timelines