Technical Writer

Life Science background with at least 5 years experience is preferred. Good communication and project management skills appropriate for leadership of tech transfer projects Working knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities Excels at working in a team environment Comfortable analyzing scientific datasets/analytical skills with excellent written skills Ability to work independently and support a large cross-functional group Some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification

salary: $64 - $69 per hour
shift: First
work hours: 8 AM - 4 PM
education: Bachelors

Responsibilities

As a member of Manufacturing Sciences, the Technical Writer will provide written
documentation expertise to the clinical and commercial manufacturing campaigns run at the
Parenteral Facility RTP Pharma Site. The focus of this position will be as a key leader for
investigations and project implementation for Manufacturing Sciences using their technical
expertise on fill/finish, visual inspection, and packaging.
The incumbent will be tasked with writing PPQ Protocols, PPQ Reports, data verification
activities for confirmation of source data for reports, preliminary writing for sections of the filing.
Creating the Master Sample Matrix (MSM) for Manufacturing personnel to be used for on the
production floor activities.
Qualifications/Education:
Life Science background with at least 5 years experience is preferred.
Good communication and project management skills appropriate for leadership of tech
transfer projects
Working knowledge in technical understanding of Parenteral Filling Operations (e.g.
Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into
full-scale drug product manufacturing facilities
Excels at working in a team environment
Comfortable analyzing scientific datasets/analytical skills with excellent written skills
Ability to work independently and support a large cross-functional group
Some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification,
Continued Process Verification

Skills

Technical

life science

cGMP

Qualifications

Years of experience: 5 years

Experience level:

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Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.