Job Description

Monday - Friday/ First shift (7:30 - 4pm)

Position Summary:
The RSO, Technical Writer II is an associate with a minimal level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a good understanding of current GMP and safety standards the RSO, Technical Writer II collaborates with subject matter professionals and technical specialists to plan, develop, author, edit format illustrate, update, and build new standard operating procedures and other related documentation such as PBRs, logbooks, Job aids and technical reports in support of the cGMP Manufacturing facility responsibilities include maintaining established documentation design and quality standards using performance tools (Human Performance) and leading documentation workflows to meet departmental needs.
Additional responsibilities may include administrative duties to manage and process-controlled documents for the manufacturing processes.


Responsibilities:
Collaborates with area SMEs or technical specialist to build or revise existing procedures or documents for use in the manufacturing processes
Acquires and verifies accuracy of technical details, manages documentation workflows and schedules and proofreads drafts for adherence to established document design and quality standards
Performs administrative duties related to managing controlled document life cycles from issuance to Manufacturing through archival with Quality Assurance
Responsibilities may include maintaining the GMP manual of Standard Operating Procedures and management of logbooks for the manufacturing operations
Provides training to Junior associates on established writing standards for documentation design and quality
Training provided may also Include company policies, programs and procedures commensurate with their experience as a qualified trainer
Participates in initiatives to support. Innovation and continuous Improvement activities and improved compliance with quality procedures, policies and regulations


Keys to Success:
Minimum Requirements/Qualifications:
Minimum High School Diploma required with 5+ years related experience
3-4 years industry related experience with an Associate's Degree
1-2 years Industry related experience with a Bachelor's Degree

Required Experience
Strong interpersonal and communications skills; written and oral
Must be skilled in the use of a personal computer and related software applications
Must have strong Interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in diverse areas

Knowledge, Skills, Abilities:
Must be skilled in meetings and interviews to eliciting technical details from subject matter specialists
Must be able to provide effective written or verbal communication to peers, senior associates and area management within their operational group
Must be able to develop logical structure for technical documents, content and illustrations
Must be detail oriented while proofreading documents
Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety personnel, etc ) to senior specialists or area management
Must be able to understand operational documents for GMP compliance, accuracy and completeness


Physical Requirements / Work Environment
Gown aseptically and/or sterile gown as needed
Fully onsite

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