QC Technical Writer
ONSITE SALT LAKE CITY
6-month contract
Our client is seeking an experienced QC Technical Writer to support QC Chemistry and QC Microbiology activities across clinical and commercial programs. This is a 6-month position with an onsite work requirement (5 days/week) to enable close collaboration with QC scientists, subject matter experts, and cross-functional partners.
The Technical Writer will play a critical role in supporting BLA-related documentation, analytical data review, method transfer and readiness activities, and QC operational readiness. The ideal QC Technical Writer combines strong technical writing capabilities with a solid working knowledge of analytical testing and QC laboratory operations.
This is a hands-on role for someone who can understand technical and analytical information, work directly with QC SMEs, review analytical data and source documentation, and independently translate that information into clear, accurate, compliant technical documents.
Key Responsibilities
- Author, revise, and finalize technical documentation supporting QC Chemistry and QC Microbiology, including method transfer, qualification, validation, and readiness activities
- Develop and revise method transfer protocols, qualification protocols, reports, and associated technical documentation
- Support the drafting and revision of analytical methods and related QC documentation
- Develop and update SOPs and other controlled documents, with a high volume of SOP writing and revision expected
- Support documentation required for BLA and regulatory submissions, including translating complex analytical information into clear, scientifically accurate written content
- Review analytical data, laboratory documentation, and technical source materials to support accurate reports and other QC deliverables
- Draft and revise reports using established templates, including periodic and quarterly reports
- Collaborate directly with QC scientists and SMEs to understand analytical activities, resolve gaps or inconsistencies, and ensure technical accuracy
- Support analytical method transfers and technology transfer activities, including documentation required for transfer readiness
- Assist with documentation packages supporting method validation, qualification, PPQ readiness, and overall QC operational readiness
- Ensure documentation is scientifically accurate, clear, consistent, and aligned with GMP, data integrity, and internal quality requirements
- Manage document lifecycle activities including formatting, review coordination, revisions, version control, and incorporation of SME feedback
- Work closely with the QC team onsite to facilitate efficient communication, obtain technical input, and reduce the documentation burden on QC scientists
- Identify missing or unclear technical information and proactively work with SMEs to obtain the information needed to complete high-quality documentation
Required Qualifications
- Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or a related scientific discipline
- 5+ years of experience in a GMP-regulated pharmaceutical or biotechnology environment
- Experience supporting BLA or other regulatory submission-related writing
- Demonstrated experience writing technical documentation within QC, analytical, laboratory, or manufacturing environments
- Experience authoring or revising SOPs, analytical methods, protocols, reports, and other controlled GMP documentation
- Experience supporting method transfer, qualification, validation, or technology transfer activities
- Ability to independently review and understand analytical data and technical source documentation
- Strong understanding of GMP documentation practices and data integrity principles
- Excellent written and verbal communication skills with the ability to work directly with technical SMEs
- Ability and willingness to work onsite and collaborate closely with the QC team
Preferred Qualifications
- Experience supporting QC activities across both clinical and commercial programs
- Direct QC or laboratory experience in addition to technical writing experience
- Strong analytical background with experience in techniques such as HPLC, CE-SDS, ELISA, potency assays, or related analytical methods
- Experience with QC Microbiology testing such as endotoxin, bioburden, sterility, or related microbiological assays
- Experience supporting analytical method transfers and technology transfers
- Experience with PPQ readiness and associated QC documentation
- Experience working with biologics and/or complex pharmaceutical products
- Experience with document management systems such as MasterControl
- Experience reviewing analytical data and drafting reports based on technical source information
