Quality Control Technical Writer
Redbock - an NES Fircroft company, Salt Lake City, UT, United States
Our client is a biotechnology company seeking a contract QC Technical Writer to support method transfer and readiness activities for QC Chemistry and QC Microbiology. This role will focus on authoring and revising technical documents to support analytical method transfers, qualification activities, and overall QC operational readiness.
This role will play a critical part in enabling timely QC readiness by reducing the documentation burden on QC scientists and ensuring high-quality, compliant deliverables for method transfer, qualification activities, and PPQ (Process Performance Qualification) readiness.
Note, documentation has already been interpreted in English*
This is a 6-9 month contract assignment. Strong preference for local candidates to Salt Lake City, however remote candidates will be considered.
Key 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)
Required Qualifications
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
Preferred Qualifications
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
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This role will play a critical part in enabling timely QC readiness by reducing the documentation burden on QC scientists and ensuring high-quality, compliant deliverables for method transfer, qualification activities, and PPQ (Process Performance Qualification) readiness.
Note, documentation has already been interpreted in English*
This is a 6-9 month contract assignment. Strong preference for local candidates to Salt Lake City, however remote candidates will be considered.
Key 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)
Required Qualifications
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
Preferred Qualifications
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
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