Technical Writer (Springfield, NJ)
- Technical Documentation: Author, edit, and maintain a wide range of documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, technical reports, change control documents, and regulatory submissions in accordance with GMP guidelines.
- Compliance: Ensure all written materials meet regulatory and GMP requirements, and align with the company’s quality standards, procedures, and policies.
- Collaboration: Work closely with both Client stakeholders and client stakeholders to establish alignment on deliverables and ensure project timelines are maintained.
- Document Management: Assist in the management of controlled documents in document control systems (e.g., electronic document management systems), ensuring traceability, version control, and appropriate distribution of approved documents.
- Process Improvement: Participate in process improvement initiatives related to document control, writing standards, and compliance, ensuring continuous enhancement of documentation practices.
- Audits & Inspections: Support internal and external audits by preparing relevant documentation and ensuring that all technical writing adheres to current regulatory standards.
- Change Control: Document and track changes in manufacturing processes, equipment, and methodologies, ensuring updates to procedures and records are properly reflected.
- Education: Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or a related field. Advanced degree or certification in technical writing is a plus.
- Experience:
- Minimum of 2 years of experience in technical writing within a GMP-regulated environment in the pharmaceutical, biotech, or related industry.
- Experience writing technical documentation, including SOPs, validation protocols, and reports.
- Knowledge:
- Solid understanding of GMP regulations (FDA, EMA, ISO, ICH, etc.) and regulatory requirements for pharmaceutical manufacturing.
- Proficiency with document management systems and Microsoft Office Suite (Word, Excel, PowerPoint).
- Skills:
- Exceptional written and verbal communication skills, with a strong ability to translate complex technical concepts into clear, concise documentation.
- Detail-oriented with strong organizational and project management skills.
- Ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
- Strong analytical and problem-solving skills, with the ability to work cross-functionally across departments.
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