- San Diego, CA
Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulatory affairs and validation.
Sequoia's hands-on consultants provide technical knowledge and relevant life science experience to establish best practices in manufacturing, pharmaceutical and medical device companies. We are helping to produce better, faster and more economically priced medicines and medical devices around the world.
Sequoia is seeking a Technical Writer who will write, edit, revise, and process GMP documentation. This key individual will maintain standardized and consistent documentation practices while partnering with Document Control to create and process document change requests and justifications. The ideal candidate must be able to communicate and collaborate with Subject Matter Experts (SMEs) to develop, write and revise control documents. The Technical Writer is expected to Track and provide document status updates to team leaders and managers as needed. S/he is expected to think critically and see gaps in products or processes, show initiative and good judgment in developing solutions, and then train writers or other stakeholders so that those solutions can be applied more broadly.
- Manage multiple document reviews and approval workflows in EDMS.
- Maintain standardized language and documentation practices that allow for consistent execution of documents.
- Establish and support documentation practices that reduce review times and deviation by researching errors and inconsistencies in existing documents and communicating effectively with appropriate personnel.
- Collaborate with representatives of multiple departments on projects.
- Quickly learn and apply new tools, processes, and scientific information.
- Help build a strong training infrastructure so that all writers benefit from new discoveries and developments.
- Train and mentor new writers.
- Bachelor's Degree or equivalent; scientific knowledge a plus.
- 5+ years of experience as a technical writer in Biotech/Pharma/Med-Device industry.
- Pharma/Biotech technical writing experience including manufacturing standard operation procedures, instructions and validation report.
- Experience in a FDA regulated environment is a must.
- Knowledgeable in FDA GMPs (21 CFR, 210, 211, 820, and/or 600).
- Excellent written and oral communication skills, ability to work in a fast-paced team oriented environment.
- Experience in a biotech/pharmaceutical laboratory and/or manufacturing environment.
- Well organized and detail oriented; Ability to handle multiple projects.
- Able to successfully execute projects/tasks with minimal oversight.
- Proficiency in Word, including styles, tables.
Sequoia offers a comprehensive suite of benefits including, medical, dental and vision coverage, 401k and company paid life-insurance.
Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.