Pharmaceutical Technical Writer

Our client is looking to fill the role of Pharmaceutical Technical Writer. The Technical Writer serves as the primary documentation specialist for commercial manufacturing operations and technical transfer processes. This role encompasses comprehensive document management, process improvement initiatives, and specialized support for R&D documentation requirements. The position involves evaluating current documentation systems (Batch Records, SOPs, OIMs), identifying enhancement opportunities, and executing improvements that advance Manufacturing's continuous improvement objectives.

Responsibilities:

Documentation Management & Development

• Deliver comprehensive documentation support to Technical Services team, encompassing creation, revision, formatting, processing, archival, and maintenance of both physical and electronic documents
• Develop and maintain critical documentation including batch production records, standard operating procedures, protocols, and technical reports
• Prepare incident documentation, investigation summaries, and quality event reports with accuracy and timeliness

Quality Systems Administration

• Administer Quality Systems processes for Technical Services, including CAPA management, Change Control procedures, and quality event tracking and analysis
• Collaborate with subject matter experts to develop and document effective Corrective and Preventive Actions (CAPA), ensuring complete and compliant documentation
• Serve as departmental Subject Matter Expert for Electronic Quality Documentation Management Systems, providing user support and training as required

Regulatory Compliance & Reviews

• Lead the biennial SOP review cycle for Technical Services, managing revisions and ensuring adherence to established timelines
• Coordinate Validation Section contributions to Periodic Quality Reviews (PQRs), including data compilation, document preparation, and CAPA identification
• Maintain strict compliance with FDA regulations, cGMP guidelines, and all applicable regulatory standards

Scientific Communication & Marketing Support

• Facilitate development of scientific publications and technical materials that enhance Adare Technologies' market presence and support business development initiatives
• Create diverse content for Technical Services and R&D departments including research papers, conference posters, white papers, presentations, and webinar materials

Operational Excellence

• Champion continuous improvement initiatives across departmental functions
• Promote and support Safety and cGMP program implementation
• Ensure adherence to all regulatory frameworks (GMP, ISO, FDA, internal policies) within scope of responsibility

Required Qualifications:

Education & Experience

• High School diploma with 3-5 years of technical writing and procedure development experience in FDA-regulated environments, OR
• Bachelor's degree with 2-3 years of technical writing and procedure development experience in FDA-regulated environments

Technical Proficiencies

• Advanced proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
• Demonstrated capability in data synthesis from multiple sources and creation of comprehensive reports and executive summaries
• Proven track record of producing clear, logical, and consistent written communications

If you meet the required qualifications and are interested in this role, please apply today.

The Solomon Page Distinction

Solomon Page offers a comprehensive benefit program for hourly employees. We pride ourselves on offering medical, dental, 401(k), direct deposit and commuter benefits to our employees, including freelancers - which sets us apart in the industries we serve.

About Solomon Page

Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: solomonpage.com and connect with us on Facebook, and LinkedIn.

Opportunity Awaits.

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