Temporary Technical Writer
Job Description
Job Description: H ybrid position
Purpose and Scope of Position:
Manufacturing Technical Writers work cross-functionally with Manufacturing, MS&T, and Quality groups to lead MO deviation investigations, and author/revise GMP documentation to support clinical and commercial lot release for 2 CAR T products. The Technical Writer will also be responsible for working with the MO and QA teams to agree on appropriate CAPSs as needed and ensure on time implementation and closure of actions. Technical writers will write, revise and review all related GMP documentation for S12 CAR T manufacturing operations including SOPs, Batch Records, and Work Instructions.
Required Competencies: Knowledge/ Skills, and Abilities:
- Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- Strong technical and compliance writing capability
- Proficient in MS Office applications
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Previous experience leading and closing deviation investigations to support lot release
Duties and Responsibilities:
- Lead Manufacturing NOEs and deviation investigations to ensure on time closure
- Responsible for opening change controls as needed to revise Batch Records, SOPs, Work Instructions to support new product/process implementation, and close CAPAs
- Participate in cross-functional deviation and CAPA meetings and initiatives in S12
- Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to appropriately assign deviation investigations and CAPAs, and support closure
- Serve as a credible SME as needed during audits to present and defend deviation investigations
- Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations
- Other duties may be assigned, as necessary. Education and Experience:
- Master’s degree plus 2 years of experience Manufacturing Technical Writing or in a QA role
OR Bachelor’s degree plus 3-4 years of experience in Manufacturing Technical Writing or in a QA role
OR Associate/ Medical Technical degree and 8 years of Manufacturing or Operations experience
OR High School diploma/GED and 10 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA.
Working Conditions:
- Primarily office based, but some on floor/clean room interactions may be required.
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
- Reagents, chemicals, and exposure to sanitization agents could be expected.
- Potential exposure to human blood components and strong magnets.
- Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum.
How to Apply
candidates can email resumes To annette.george@axelon.com280 total views, 0 today