- 186056 - New Product Development Technical Writer & Document Manager
- CA-Central California
- West Hills
- Up to $27.99 DOE
- 12 mos
- Chipton-Ross is seeking a New Product Development Technical Writer & Document Manager for an opening in West Hills, CA.
Increased innovation, along with substantial growth in the Transplant Diagnostics business, has resulted in a need for additional Project Management support for new product development documentation. The individual in this role will assist Project Teams achieve goals and objectives set by the Senior Leadership Team.
The New Product Development Document Manager will be expected to partner with all Departments in ensuring that the organization achieves its goals. Performance of this individual’s responsibilities will require good knowledge of regulatory requirements and quality systems required for in vitro diagnostic (IVD) products.
Lead and/or participate in the development of new documents or update existing documentation used for new product development. Ensure consistency between documents by reviewing and editing for completeness. Rewrite documents to be accurate, clear and concise. Participate in the development and maintenance of document standards, naming/numbering conventions, and templates for Design History File (DHF) procedures, work instructions, and other relevant document types. Ensure that documents comply with established templates, formats and identification/naming/numbering standards. Support/manage document workflow and ensure compliance. Ensure that document reviews and approvals are managed in an efficient and effective manner. Assist in the identification and removal of old/obsolete procedures and work instructions, as required. Manage and control specific quality records, as required.
The candidate should have Technical Writing experience, preferably someone with In Vitro Diagnostic (IVD) devices, who is capable of creating and finalizing highly detailed documentation in the area of IVD. Verification and Validation, Instructions for Use and other design input documents. Excellent written and verbal communication skills, possess a strong sense of responsibility and urgency. This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner. Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety). Strong knowledge of medical device and/or pharmaceutical regulations (FDA, ISO). A minimum of 2 years of experience in document control or training, applying regulations and/or standards such: as FDA, Sirs, ISO, etc. Strong process improvement mindset; passion for quality. Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation). Demonstrated effective interpersonal and effective teamwork skills. Excellent oral and written communication skills. Analytical & problem-solving skills/root-cause analysis. Strong organizational skills with high attention to detail. Prior experience using word processing, spreadsheet, and presentation software.
Accredited Bachelor’s (Required) in a scientific or technical field.
Shift: M-F, 9-5
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 x252 or (800) 927-9318 x252
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.