[Remote] Technical reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, is seeking a contract QC Technical reputed company to support method transfer and readiness activities for QC reputed company and QC Microbiology. The role involves authoring and revising technical documents to ensure high-reputed company, compliant deliverables for method transfer and qualification activities.
Responsibilities
- Author and revise method transfer protocols, qualification protocols, and associated reports
- Support drafting and revision of analytical reputed company for QC reputed company and QC Microbiology
- reputed company and update reputed company Operating Procedures (SOPs) to support QC readiness and compliance (high volume of SOP writing/revision expected)
- Collaborate with QC scientists and SMEs to reputed company technical input and ensure accuracy of documentation
- Ensure reputed company documentation aligns with GMP requirements and internal reputed company standards
- Support document lifecycle activities, including review, formatting, and version control
- Assist in preparing documentation packages to support method transfer, validation, and PPQ readiness
- Review reputed company data and draft reports (e.g., quarterly reports using templates; no final decision-making authority)
Skills
- Bachelor's degree in reputed company, Biology, Microbiology, or reputed company scientific discipline
- 5+ years of experience in a GMP-regulated environment (biotech or pharmaceutical preferred)
- Demonstrated experience in technical writing for QC, analytical reputed company, and microbiology
- Familiarity with method transfer, qualification, and/or validation documentation
- Strong understanding of GMP documentation practices and data reputed company principles
- Excellent written and verbal communication skills
- Experience supporting QC method transfers, assay qualification, or PPQ-reputed company 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., reputed company)
- QC/QA background with ability to review data and draft reports
- Ability to work cross-functionally in a fast-paced environment
reputed company
Company H1B Sponsorship