QC Technical Writer

W2 Contract

Pay Rate: $60 - $67 per hour

Location: Salt Lake City, UT - Remote Role

Job Summary:

We are 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.

Duties and 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
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 and validation readiness

Requirements and Qualifications:

Bachelor's degree in chemistry, Biology, Microbiology, or a 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 or assay qualification 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)
Ability to work cross-functionally in a fast-paced environment

Desired Skills and Experience

QC technical writing, QC Chemistry and Microbiology, analytical method authoring and revision, method transfer protocols and reports, qualification and validation documentation, assay qualification, SOP development, QC operational readiness, GMP compliance and documentation practices, data integrity, document review and formatting, version control, document lifecycle management, MasterControl, HPLC, CE-SDS, ELISA, potency assays, endotoxin and bioburden testing, cross-functional and SME collaboration, written and verbal communication, scientific bachelor's degree, 5+ years of GMP-regulated experience

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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QC Technical Writer