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Senior Technical Writer - Reedsville, PA Hybrid at Reedsville, Wisconsin, USA
Email: [email protected]
Senior
Technical Writer

Reedsville, PA  Hybrid

Duration: Through March 2025, with potential for extension
based on project needs

Rate:
$35-40/hr. on C2C 

Client
- Confidential 

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.

Thanks

Abhishek 

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Keywords: information technology Pennsylvania
Senior Technical Writer - Reedsville, PA Hybrid
[email protected]
[email protected]
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Thu Sep 12 01:29:00 UTC 2024

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Location: Reedsville, Pennsylvania