Technical Writer

Technical Writer
  • $25.39 - $42.32 per Hour
  • Temporary
  • Hayward CA, US Hayward ALAMEDA US 94545
Job Ref: JO000120271
Sector: Science
Sub-sector: Science- Bio
Date Added: 13 July 2021

Technical Writer III - 6 month renewable contract

Key Words: Technical Writing Pharma, Technical Documentation GMP, Data Integrity, ALCOA, CSV


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.
Key Accountabilities and Duties:

? 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.
Minimum Required Qualifications/Skills:
? 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

Preferred Experience:
? Prior experience in a GMP regulated laboratory / manufacturing environment
? Understanding of GMP and data integrity (ALCOA+)

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

12/08/2021 12:00:00
USD 25.39 42.32 Hour
Contact Consultant:
Jennifer Law

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