Technical Writer Job Summary
Bioscension Laboratory Services is seeking a detail-oriented Technical Writer to support the development of technical, quality, validation, and regulatory documentation for laboratory testing programs, medical device validations, healthcare water quality monitoring programs, and quality management system activities.
The Technical Writer will work closely with laboratory scientists, quality personnel, project coordinators, and technical subject matter experts to transform technical information into clear, accurate, compliant, and defensible documentation. This position plays a critical role in ensuring that project deliverables are scientifically sound, professionally presented, traceable, and aligned with applicable regulatory requirements, accreditation standards, and client expectations.
The ideal candidate possesses exceptional writing and organizational skills, a strong attention to detail, and the ability to understand and communicate complex scientific and technical concepts.
Key ResponsibilitiesTechnical Documentation Development
- Draft, revise, and maintain technical documentation supporting laboratory operations, validation studies, and client programs.
- Prepare validation plans, study protocols, testing plans, technical reports, summary reports, and final project deliverables.
- Develop and maintain standard operating procedures (SOPs), work instructions, forms, templates, and quality system documentation.
- Assist in the preparation of technical justifications, scientific rationales, and supporting documentation used to defend testing approaches and validation strategies.
- Ensure documentation is technically accurate, consistent, traceable, and aligned with project objectives.
Validation & Study Documentation
- Support documentation activities associated with microbiological testing, chemical testing, cleaning validations, sterilization validations, environmental monitoring programs, and healthcare water quality monitoring programs.
- Collaborate with technical experts to document study designs, acceptance criteria, sampling plans, test methodologies, and validation approaches.
- Compile study results, observations, deviations, corrective actions, and conclusions into professional client-facing reports.
- Ensure supporting data, attachments, calculations, and references are properly incorporated into final deliverables.
Quality & Regulatory Documentation
- Support maintenance of documentation required under ISO/IEC 17025 quality system requirements.
- Assist with document control activities, revision management, change tracking, and archival of quality records.
- Participate in the development of audit responses, corrective action documentation, quality investigations, and compliance-related communications.
- Ensure documentation supports laboratory requirements for accuracy, confidentiality, impartiality, traceability, and technical defensibility.
Program & Project Support
- Collaborate with project coordinators and laboratory personnel to ensure documentation is prepared in accordance with project timelines and client commitments.
- Review project documentation packages for completeness and consistency before client issuance.
- Support development of proposals, statements of work, technical summaries, marketing materials, white papers, and scientific communications when needed.
- Assist with development of new service offerings, accreditation scope expansions, and technical program documentation.
Required Qualifications
- Bachelor's degree in Technical Writing, English, Communications, Journalism, Professional Writing, Life Sciences, Engineering, or a related field.
- Exceptional technical writing, editing, proofreading, and document formatting skills.
- Strong attention to detail and organizational abilities.
- Ability to understand complex scientific and technical concepts and communicate them clearly to diverse audiences.
- Excellent interviewing and information-gathering skills.
- Proficiency with Microsoft Office Suite, document management systems, and collaborative editing platforms.
- Ability to manage multiple projects and deadlines simultaneously.
Preferred Qualifications
- Experience developing technical documentation within regulated industries.
- Experience supporting laboratory, medical device, pharmaceutical, biotechnology, healthcare, engineering, or quality-system environments.
- Familiarity with ISO/IEC 17025, ISO 13485, FDA regulations, GMP, GLP, USP, ANSI/AAMI standards, or similar quality and regulatory frameworks.
- Experience drafting validation plans, study protocols, technical reports, quality documents, audit responses, regulatory submissions, or scientific publications.
- Basic understanding of microbiology, chemistry, laboratory operations, validation activities, or healthcare quality systems.
Key Characteristics for Success
The ideal candidate is analytical, organized, detail-oriented, and passionate about producing high-quality documentation. This individual must be comfortable working closely with technical experts to translate complex scientific concepts into clear, professional, and defensible documentation that supports client objectives, regulatory compliance, and laboratory quality standards.
At Bioscension Laboratory Services, documentation is a critical component of quality, compliance, and client success. The Technical Writer & Documentation Specialist plays a key role in ensuring that our technical work is effectively communicated, properly documented, and defensible from both scientific and regulatory perspectives.
Pay: $25.00 - $32.00 per hour
Benefits:
- Flexible schedule
- Professional development assistance
- Referral program
Education:
Experience:
- Technical writing: 2 years (Required)
- Laboratory: 2 years (Preferred)
Language:
Location:
- Miamisburg, OH 45342 (Preferred)
Ability to Commute:
- Miamisburg, OH 45342 (Preferred)
Work Location: Hybrid remote in Miamisburg, OH 45342
