Technical Writer (GMP)
Actalent
Posted Friday, September 27, 2024
Posting ID: JP-004778531
Technical Writer Needed- Urgently Hiring
This is a contract position for 6 months, this role requires a relevant four-year Science degree either a bachelors of Science or Masters degree of Science. The ideal candidate would have 1+yrs of Technical Writing experience from a GMP setting preferably from a Life Science/Pharma Company, experience in Biologics, Gene Therapy, or Pharmaceutics and knowledge of GMP, regulatory (FDA) requirements, and understanding of aseptic processes.
Job Description
We are seeking a meticulous Technical Writer to join our team. In this role, you will write deviations when SOPs are not followed, ensuring the product remains compliant with standards. You will also write batch records, update and create SOPs, and create one-point lessons. You will partner with a Documentation Specialist to prioritize workloads and interact with technical staff to gather necessary information. You will exercise discretion, judgment, and personal responsibility while maintaining a positive attitude and high integrity. Compliance with regulatory requirements for cellular and gene therapy products and attention to detail are crucial. You will solve, correct, and prevent problems, perform tasks as assigned by leadership, and assign tasks to junior staff. You will work towards specific measurable objectives with minimal supervision, lead a diverse and collaborative team, and document all activities according to SOPs.
Hard Skills
- Quality Assurance
- Biology
- Deviations
- GMP
- Technical Writing
Soft Skills
- Discretion
- Judgment
- Personal Responsibility
- Integrity
- Positive Attitude
- Attention to Detail
- Operational Planning
- Collaboration
- Clear Communication
Job Type
This is a contract position with a duration of 6 Month(s).
Work Site
This is a fully on-site position in Columbus, Ohio.
Work Environment
This is an office-based environment with a business casual dress code. The position operates on a 1st shift schedule, Monday to Friday, 8:00 AM to 4:30 PM, with some flexibility and occasional overtime
Interested candidates can send updated resumes to: jgasser @ actalentservices.com
Contact Information
Email: wdavy@actalentservices.com