Vacancy expired!
Sunrise System Inc. is currently looking for
Technical Writer III in Hayward, CA with one of our top client. Job Title: Technical Writer IIIJob Id: 21-06905Location: Hayward, CA 94545Duration: 6 monthsPosition Type: Hourly contract Position (W2 only) Description- Technical Writer Level III offers precise and accurate writing, editing, and planning skills and brings a greater leadership role within the engineering group at Lonza. This position provides support within the department and also throughout the business, offering keen insight to process-related knowledge and manufacturing as related to data integrity, computer system validation and technical engineering SOPs.
- Technical Writer Level III has a deep understanding of how their work directly affects ease of operations within the building, patient safety, drug quality, and business reputation.
- Edit and create documents following predefined Lonza templates/standards: Review and template documents with accurate, clear, and explicit description and justifications while developing proficiency in both data integrity and computer system validation principles.
- Creates new cGMP documents with minimal assistance.
- Manage document DMS workflow (Review, response to comments and approval): Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the aid of document owners, SMEs and QA.
- Able to author any CAPAs related to data integrity & commercialization events.
- Review and maintain document schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe with minimal oversight.
- Become proficient in both data integrity and computer system validation processes and procedures.
- Support and implement continuous improvement initiatives.
- Strong written and oral communication skills
- Detail oriented
- Advanced proficiency in MS Suite, particularly Word, Excel
- Word Processing experience
- Able to navigate in an electronic quality management system (TrackWise) and major content management systems (DMS).
- Highly organized
- Proofreading/editing
- Prior experience in a GMP regulated laboratory / manufacturing environment
- Understanding of GMP and data integrity (ALCOA+)
Vacancy expired!