Technical Writer III

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.

location: Durham, North Carolina
job type: Contract
salary: $50 - 62 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• 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:
Qualifications

• 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

#LI-AM1

skills: Good Manufacturing Practices (GMP)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

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.