Technical Writer

USA-Documentation Specialist I (Manufacturing/Quality) 1st Shift

1 Year9-5, EST; Mon-Fri (Some Flexibility)

Framingham, MA

Max PR: $37.55/ hr

RESPONSIBILITIES

• Track and review change control documentation.
• Assist with the editing of quality documents (SOPs, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements.
• Must be able to work quickly with a high degree of accuracy.
• Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
• Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation.
• Translate business specifications into user documentation.
• Plan, write, and maintain systems and user support documentation efforts; including online help screens.
• Knowledgeable of commonly used concepts, practices, and procedures within a particular field.
• Rely on instructions and pre-established guidelines to perform the functions of the job.

EDUCATION / REQUIREMENTS

• Must Have:
• Previous GMP Experience
• SOP, Guidelines, Log Sheets
• Min of 1-3 Years of Experience
• MS Office, Excel (data/entry level), Share point, Outlook, Teams
• Detailed Orientated
• Ability to read/ write in English
• Must have the ability to gown up as needed – enter clean rooms (jewelry must be removed for this process)
• Nice to Have/ Preferred Skills:
• Preferred AA or Bachelor’s degree
• Preferred 3-5 Years of Experience