- 179955 - Technical Writer II
- CA-Bay Area
- 5 Montns
- Chipton-Ross is seeking a Technical Writer II for an opening in Fremont, CA.
We are looking for innovative candidates to be a key contributor in supporting the development of software product that impact on patient lives. The candidate will support R&D with primary responsibility for the hands-on management of documentation supporting software diagnostics product development and on-market product improvements. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase-gate development of new products and the transfer of products from R&D to production.
This role will be dedicated to managing and updating Safety Data Sheets for in vitro diagnostic products. In addition, the role will assist the Regulatory Affairs team in preparing documentation including supporting administrative activities.
The ideal candidate will be a true team player, with strong Project Management skills . This is an opportunity for a highly motivated candidate to work alongside chemists, molecular biologists, and quality engineers in a fast-paced environment.
•Liase with groups in several geographic locations, to update Safety Data Sheets.
•Perform document reviews and makes determinations as to whether document meets procedural and regulatory expectations. Communicates and coordinates with other departments as required to resolve issues detected during review.
•Submit and complete document change requests.
•Maintain tracking sheets and report out project status updates. Follow up with team members to ensure timely implementation of updates.
•Support Regulatory Activities by preparing and assembling documentation for international registrations as required.
•Experience in IVD field
•Must be able to work independently taking general concepts and direction to produce desirable compliant outcomes.
•Ability to prioritize multiple tasks and to function effectively in a global, multi-site organization.
•Detail-oriented and accurate while maintaining a vision of the end result.
•Excellent verbal and written communication skills
•Skills in Microsoft Office
•Ability to work in a fast paced environment
•Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community
Accredited Bachelor’s Degree in a science, engineering or related field.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.