Senior Technical Writer This is onsite will possibly consider hybrid at a later date
Senior Technical Writer This is onsite will possibly consider hybrid at a later date
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Job Description
Title: Senior Technical Writer
Location: Reedsville PA must be local or willing to relo immediately ( This is onsite will possibly consider hybrid at a later date)
Visa: USC/GC
Client domain: Manufacturing
Duration: Through March 2025 with potential for extension based on project needs
Position Summary
We are seeking a highly experienced Senior Technical Writer to take ownership of the documentation process for a critical project.
This role is essential in ensuring that documentation is completed efficiently accurately and fully compliant with FDA and ISO standards.
The Senior Technical Writer will collaborate closely with crossfunctional teams especially in Quality Engineering to ensure that all technical documents are of the highest standard and align with regulatory requirements.
Position Scope and Key Deliverables
- The company has a fully compliant ISO 13485 / 21 CFR 820 Quality Management System (QMS) in place. This role will focus on creating quality and operational procedures (SOPs) to support adding a new manufacturing process to the site.
- Key milestones include drafting primary compounding documentation before Operational Qualification (OQ) with final versions released before Performance Qualification (PQ). Similar timelines apply for secondary compounding and molding processes though exact dates are currently in flux.
- The team utilizes an electronic document control system (IQS) for document management and approval. Microsoft Suite is used for document creation and editing.
Key Responsibilities
- Lead the development review and management of comprehensive technical documentation including Standard Operating Procedures (SOPs) Work Instructions (WIs) and qualification protocols (IQ OQ PQ)
- Serve as the primary point of contact for all documentationrelated activities ensuring that crossfunctional teams (Engineering Quality Assurance Regulatory) are aligned and documentation is accurate consistent and complete
- Oversee the document review and approval process maintaining strict adherence to FDA GMP and ISO 13485:2016 regulatory guidelines
- Manage document version control and maintain an organized document repository to ensure traceability accessibility and compliance
- Provide expertise in regulatory submissions ensuring that all documentation is auditready and meets FDA standards for Class I and II medical devices
- Lead efforts to streamline and improve the documentation process contributing to the development of documentation best practices
- Work closely with the Quality Management System (QMS) to ensure all documentation is in full compliance with internal policies and external regulations
- Mentor and guide junior team members or other technical writers as needed to ensure quality documentation across the team
Qualifications
- 7 years of technical writing experience with a strong focus on regulated industries such as medical devices pharmaceuticals or biotechnology
- Extensive experience working with FDA and ISO 13485:2016 standards with a proven track record of delivering highquality compliant technical documentation
- Strong understanding of Good Manufacturing Practices (GMP) and experience in Quality Management Systems (QMS)
- Demonstrated ability to lead complex documentation projects manage multiple priorities and meet tight deadlines
- Excellent written and verbal communication skills with the ability to present complex technical information clearly and concisely to various audiences
- Highly detailoriented with a commitment to producing errorfree documentation
- Strong leadership skills with the ability to collaborate effectively within crossfunctional teams and mentor junior staff
- Familiarity with electronic document management systems and change control processes in a regulated environment
Additional Information
This position is based onsite in Reedsville PA and may require overtime or weekend work to meet critical project deadlines.
The Senior Technical Writer will operate in a fastpaced highly regulated environment where precision compliance and collaboration are key to success.
Employment Type
Full Time
