QC Technical Writer (Contract)
Bayside Solutions, Salt Lake City, UT, United States
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 Technical writing, QC documentation, method transfer protocols, qualification protocols, analytical method authoring, SOP development, GMP compliance, GMP documentation practices, data integrity, QC Chemistry, QC Microbiology, microbiology documentation, analytical methods, validation documentation, document lifecycle management, document review, formatting and version control, documentation packages, method transfer support, assay qualification, cross-functional collaboration, SME collaboration, scientific documentation, HPLC, CE-SDS, ELISA, potency assays, endotoxin testing, bioburden testing, document management systems, MasterControl, regulatory compliance, quality standards, communication skills
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
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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 Technical writing, QC documentation, method transfer protocols, qualification protocols, analytical method authoring, SOP development, GMP compliance, GMP documentation practices, data integrity, QC Chemistry, QC Microbiology, microbiology documentation, analytical methods, validation documentation, document lifecycle management, document review, formatting and version control, documentation packages, method transfer support, assay qualification, cross-functional collaboration, SME collaboration, scientific documentation, HPLC, CE-SDS, ELISA, potency assays, endotoxin testing, bioburden testing, document management systems, MasterControl, regulatory compliance, quality standards, communication skills
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.
Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
#J-18808-Ljbffr