| Location | Salt Lake City, UT |
Hello,
I hope you're doing well.
My name is Uzma Kousar Mohammed, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a QC Technical Writer based in Salt Lake City, UT with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at
uzma.kousar@intellectt.com
.
Position: QC Technical Writer
Location: Salt Lake City, UT (Looking for locals only)
About the job:
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.
Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Thanks & Regards,
Uzma Kousar Mohammed
Technical Recruiter
Intellectt Inc
uzma.kousar@intellectt.com