Technical Writer in Springfield, MO
The Technical Writer creates manufacturing batch records and supportive documents, both in paper and electronic format. Writes, and edits technical documents related to pharmaceutical manufacturing by working with cross functional teams. Has advanced Microsoft Word and computer literacy skills to creating efficient, accurate documents while remaining compliant with the regulatory requirements. Sets priorities to ensure documents are ready when needed per the production schedule. Be a leader in implementing electronic batch records at the site.
Essential Duties and Responsibilities:
Creates or revises and manages the workflow for MFG documents
Determines reviewers/ approvers based upon the changes requested and the document type
Obtains technical content from Subject Matter Experts (SMEs) including Bill of Materials, Equipment list, Process Parameters
Drafts new / revises existing documents using current templates
Follows up with the reviewers/ approvers and address comments
Coordinates the document workflow
Work with end users to ensure document has appropriate prompts/space to fill in required execution information
Ensures accurate references within document and to other documents
Continuous improvement of batch record templates based on feedback from MFG operations, QA and other stakeholders
Facilitates meetings to resolve / address comments (if the document revision is extensive), and to reach consensus with multiple stakeholders
Authors manufacturing summary documents for clients
Requirements:
Minimum two (2) year work experience in GMP regulated industry; or Associates/Bachelor’s degree in chemical engineering or related degree..
Knowledge pharmaceutical manufacturing or documentation management system processes experience.
Advanced proficiency in MS Word and computer literacy.
Technical writing experience of one (1) year with a certificate in Technical writing is highly desirable.
Quick learner, understanding of presented technical/scientific content.
Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
Keen attention to detail and high regard for quality.
Experience working in a self-driven, performance/results oriented, fast paced environment.
Must be highly collaborative and can work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community.
Pharmaceutical manufacturing floor operations, training, validation, quality assurance experience in a pharmaceutical industry is highly desirable.
All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.