Technical Writer - Life Science

Technical Writer

Duration: 06 months with possible extension Office:
Research Triangle Park, NC 27709 Pay rate: $60/hr. on W2

Job Summary:

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

Required:

• Life Science background with at least 5 years' experience.
• 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.

About Us:

Founded in 2009, Intelli Pro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.

Intelli Pro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, Intelli Pro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants.

Compensation:

The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, Intelli Pro provides a comprehensive benefits package, all subject to eligibility.