QC Technical Writer

Virtue America • Contract • Utah, United States, US • 1d ago

Role : QC Technical Writer

Location : Utah

Duration :6-Month | Onsite

Note : Contract On W2

Our client is seeking an experienced QC Technical Writer to support QC Chemistry and QC Microbiology activities across both clinical and commercial programs.

This is a 6-month onsite opportunity in Utah, with a 5-day/week onsite schedule. The ideal candidate will have strong technical writing skills combined with hands-on knowledge of QC laboratory operations, analytical testing, GMP documentation, and regulatory requirements.

Key Responsibilities :-

Author, revise, and finalize technical documentation supporting QC Chemistry and QC Microbiology activities.
Develop and update method transfer protocols, qualification protocols, validation documents, reports, analytical methods, and SOPs.
Support BLA and regulatory submission documentation, translating complex analytical information into clear and scientifically accurate content.
Review analytical data, laboratory records, and technical source documents.
Prepare periodic, quarterly, validation, method transfer, and other QC reports.
Partner closely with QC Scientists and SMEs to gather technical information and resolve documentation gaps.
Support analytical method transfer, technology transfer, PPQ readiness, and QC operational readiness.
Ensure all documentation aligns with GMP, data integrity, and internal quality standards.
Manage document revisions, formatting, review cycles, version control, and SME feedback.
Proactively identify missing or unclear information and work with SMEs to complete accurate documentation.

Required Qualifications :-

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or a related scientific field.
5+ years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
Experience supporting BLA or regulatory submission-related documentation.
Proven experience authoring and revising SOPs, analytical methods, protocols, reports, and controlled GMP documents.
Experience with method transfer, qualification, validation, or technology transfer.
Ability to independently review and understand analytical data and technical source documentation.
Strong knowledge of GMP documentation practices and data integrity principles.
Excellent written and verbal communication skills.
Ability to work onsite 5 days per week and collaborate closely with QC teams.

Preferred Qualifications :-

Experience supporting clinical and commercial QC programs.
Direct QC laboratory experience in addition to technical writing.
Experience with analytical techniques such as HPLC, CE-SDS, ELISA, potency assays, or related methods.
QC Microbiology experience with endotoxin, bioburden, sterility, or related testing.
Experience supporting PPQ readiness and QC documentation.
Experience working with biologics and complex pharmaceutical products.
Familiarity with MasterControl or other document management systems.
Experience reviewing analytical data and preparing technical reports.