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Summary:
Under minimal supervision, provide Technical Writing expertise and project support for manufacturing and supply chain documents. Apply Technical Writing skills, process and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to create clear, accurate and optimized procedures.
Technical Writing:
1. Initiate, revise, and approve manufacturing procedures using quality systems.
2. Work with subject matter experts to ensure procedures reflect current operations.
3. Draft and edit documents to produce clear, consistent and accurate procedures.
4. Format documents to established standards.
5. Assess document accuracy by observation of floor operations.
6. Assist in generation and revision of training materials.
7. Interact with functional groups to respond to comments during document revision and drive to resolution.
Project Management:
1. Update document schedules for revisions and product introductions.
2. Manage revision workflows so that document revisions meet the established target effective dates.
Projects and Initiatives:
1. Participate on the assessment or implementation of special projects or initiatives.
Education/Licenses:
Bachelor's Degree or Associates Degree with 4 years related experience, or High School diploma/GED with 6 years related experience
Basic Qualifications:
Technical writing experience for documents in a regulated environment
Preferred Qualifications:
Experience working with documents in a regulated industry
Understanding of GMP requirements
Ability to perform routine functions using established standards and procedures
Ability to work independently and on teams
Able to prioritize and manage multiple tasks
Ability to work in a fast paced environment
Organizational and presentation skills.
Basic project management skills.
Education/Licenses:
Bachelor's Degree or Associates Degree
with 4 years related experience, or High School diploma/GED with 6
years related experience
Basic Qualifications:
Technical writing experience for documents in a regulated environment
Preferred Qualifications:
Experience working with documents in a regulated industry
Understanding of GMP requirements
Ability to perform routine functions using established standards and procedures
Ability to work independently and on teams
Able to prioritize and manage multiple tasks
Ability to work in a fast paced environment
Organizational and presentation skills.
Basic project management skills.
