Technical Writer – Joulé Scientific, Syracuse NY

Responsibilities:

Implement solutions for continuous improvements.
Prepare document templates, statistical data evaluation and best practice guidance documents.
Sustain cGMP compliance for method validation and transfer.
Write/Review/Approve documentation (i.e., methods, protocols, reports, statistical data analysis reports).
Perform performance monitoring of methods to ensure consistent performance across the network.
Prepare analytical documents and sections in support of regulatory filings, including ROW submissions, as requested.

Requirements:

MS or BS in Biological Sciences, Chemistry, Mathematics
2 years of industrial experiences in relevant fields, respectively.
Prior experience with analytical method technical transfer and validation.
Experience with Biologics or Protein Therapeutic molecule.
Prior experience implementing continuous improvements using a LEAN Six Sigma approach.
Demonstrated knowledge and understanding of analytical test methods for protein products.
Demonstrated knowledge of the biological drug development process and regulatory requirements for submissions (i.e., GMP)
Knowledge of compendial requirements (USP, EP, JP) and Industry Guidance (e.g., ICH) is essential.
In-depth understanding of ICH guidelines for validations.

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