| Senior Technical Writer at Remote, Remote, USA |
| Email: [email protected] |
| From: Mounika, Intelligenz [email protected] Reply to: [email protected] Senior Technical Writer Reedsville, PA must be willing to relo immediately No -H1 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 cross-functional 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 documentation-related activities, ensuring that cross-functional 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 audit-ready 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 high-quality, 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 detail-oriented with a commitment to producing error-free documentation Strong leadership skills, with the ability to collaborate effectively within cross-functional 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 on-site in Reedsville, PA, and may require overtime or weekend work to meet critical project deadlines. The Senior Technical Writer will operate in a fast-paced, highly regulated environment where precision, compliance, and collaboration are key to success. Keywords: Pennsylvania Senior Technical Writer [email protected] |
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| Thu Sep 12 18:43:00 UTC 2024 |