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
? 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.
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