The Sr. Technical Writer is an enthusiastic, self-motivated person with great communication skills who can support the Quality Assurance program through creation of technical documentation. The Technical Writer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. This position will interface between the R&D and Operations teams to develop procedures that accurately capture complex processes, highlight critical steps and are compatible with information systems such as ERP and LIMS. He / She must also be comfortable in a start-up environment, while implementing documentation that supports the company’s QA systems.
The candidate will be comfortable in a rapidly evolving Biotech start-up environment assisting in the implementation of a value added QMS based on CLIA, ISO 15189:2007, ISO 13485:2003 and FDA QSR 820.30 regulations.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES :
- Research, develop, and write technical documentation (SOPs, protocols, reports, manuals, etc.) for internal and external use in accordance with Complete Genomics documentation style guidelines.
- Collaborate with subject matter experts across multiple departments to ensure quality and technical accuracy of documentation.
- Review, improve, and maintain existing documentation.
- Responsible for developing prototype documentation for laboratory and clinical operations
- Create clear and unambiguous step-by-step work instructions for complex biochemical, IT and Engineering processes
- Insure records, files, drawings, procedures, documentation comply with regulatory requirements
- Support development documentation as part of the change management (design control and tech transfer processes)
- Create and submit change order packages for DCO (Document Change Order)
- Track all planned and non-planned deviations and revise operating procedures accordingly
- Any and all other undefined tasks, as directed by your supervisor.
- Minimum: B.S. / B.A. in Molecular Biology, Engineering, Chemistry or Life Science. 5+ years as a Quality Associate or equivalent with part or all of it within a medical device or clinical laboratory environment
- Experience with:
- Creating user friendly technical documentation
- Equipment and material qualifications
- Process validation and biological assay validations
- Change Control and Management
- Quality Management Systems Planning and Implementation
- Experience in medical device / Biotech start-up/fast growth company or similar working environment (Must be able to effectively cope with occasional ambiguities and changes in priorities)
- Working knowledge of ISO13485 and FDA regulatory documentation (e.g. Device Master Records (DMR’s); Device History records (DHR’s), etc.
- An ability to understand Biochemistry and Sequencer Engineering as it pertains to DNA sequencing is required at a level to be able to assist with procedural documentation
- Working knowledge of cGMP’s is needed; experience in a CLIA environment is a plus
- Experience in Clinical Laboratory regulated environments a plus
- A working knowledge of Six Sigma, Lean techniques and methodologies a plus
- System knowledge – ERP/MRP, LIMS, File Management Systems or other data capture systems a plus
- Experience in the Product Life Cycle/Development (PLC/NPD) process and able to add quality input for design and phase reviews helpful
- Experience with other documentation tools (Framemaker, Pagemaker, etc.) helpful but not required
- Professional certification will be viewed favorably
- Fluency in written and spoken Mandarin will be viewed favorably
Complete Genomics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website, employees or Human Resources.
Complete Genomics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Complete Genomics and will be processed accordingly without fee.
Complete Genomics has the sole discretion to determine with whom we will enter into a contract. If you wish to work with Complete Genomics, please contact the Human Resources department at firstname.lastname@example.org .
Complete Genomics is proud to be an equal opportunity employer