Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, is seeking a contract QC Technical Writer to support method transfer and readiness activities for QC Chemistry and QC Microbiology. The role involves authoring and revising technical documents to ensure high-quality, compliant deliverables for method transfer and qualification activities.

Responsibilities

• Author and revise method transfer protocols, qualification protocols, and associated reports
• Support drafting and revision of analytical methods for QC Chemistry and QC Microbiology
• Develop and update Standard Operating Procedures (SOPs) to support QC readiness and compliance (high volume of SOP writing/revision expected)
• Collaborate with QC scientists and SMEs to gather technical input and ensure accuracy of documentation
• Ensure all documentation aligns with GMP requirements and internal quality standards
• Support document lifecycle activities, including review, formatting, and version control
• Assist in preparing documentation packages to support method transfer, validation, and PPQ readiness
• Review source data and draft reports (e.g., quarterly reports using templates; no final decision-making authority)

Skills

• Bachelor's degree in Chemistry, Biology, Microbiology, or related scientific discipline
• 5+ years of experience in a GMP-regulated environment (biotech or pharmaceutical preferred)
• Demonstrated experience in technical writing for QC, analytical methods, and microbiology
• Familiarity with method transfer, qualification, and/or validation documentation
• Strong understanding of GMP documentation practices and data integrity principles
• Excellent written and verbal communication skills
• Experience supporting QC method transfers, assay qualification, or PPQ-related activities
• Background in analytical techniques (e.g., HPLC, CE-SDS, ELISA, potency assays) and/or microbiological testing (e.g., endotoxin, bioburden)
• Experience with document management systems (e.g., MasterControl)
• QC/QA background with ability to review data and draft reports
• Ability to work cross-functionally in a fast-paced environment

Company Overview

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