Technical Writer

Job Title:

Technical Writer

Job Description

The Technical Writer leads and authors thorough investigations of deviations within pharmaceutical manufacturing processes, including formulation, filling, and packaging. This role ensures compliance with cGMP regulations by identifying root causes, driving effective corrective and preventive actions (CAPAs), and supporting continuous improvement initiatives across the organization. The position offers the opportunity to work in a growing company with multiple new products and an exciting pipeline.

Responsibilities

+ Lead end-to-end deviation investigations involving manufacturing operations such as aseptic and sterile filling, formulation and compounding, and packaging and inspection.

+ Identify, document, and classify deviations from standard operating procedures (SOPs), batch records, and regulatory requirements.

+ Perform structured root cause analysis (RCA) using tools such as 5 Whys and Fishbone (Ishikawa) diagrams, as well as other systematic problem-solving methods including 6M.

+ Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance (QA), Quality Control (QC), and Engineering, to determine root causes and assess impact on product quality.

+ Author clear, concise, and compliant investigation reports in accordance with cGMP and Good Documentation Practices (GDP).

+ Document all investigation findings, data analyses, risk assessments, and conclusions in an accurate and audit-ready manner.

+ Ensure timely closure of deviations with complete, compliant, and inspection-ready documentation.

+ Maintain and update investigation records within electronic Quality Management Systems (eQMS), such as Track Wise, Veeva, or ETQ.

+ Develop and implement effective Corrective and Preventive Actions (CAPAs) to address root causes and prevent recurrence of deviations.

+ Partner with site stakeholders to track CAPA progress, verify CAPA effectiveness, and ensure timely completion.

+ Support CAPA trending and contribute to continuous improvement initiatives across manufacturing operations.

+ Investigate deviations occurring on the manufacturing floor by interfacing with floor personnel to understand real-time events and process conditions.

+ Support batch record review and product disposition activities as needed to ensure product quality and compliance.

+ Ensure that all investigations and related activities comply with cGMP, internal SOPs, and applicable regulatory expectations.

+ Participate in internal and external audits and regulatory inspections by providing documentation and subject matter expertise on investigations and CAPAs.

+ Analyze deviation and CAPA trends to identify opportunities for process optimization and quality improvement.

+ Contribute to the revision of SOPs and related documentation based on investigation learnings and improvement initiatives.

+ Support and, when appropriate, deliver training initiatives related to deviation management, root cause analysis, CAPA, and documentation best practices.

Essential Skills

+ Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field.

+ Experience working in a pharmaceutical, biotechnology, or other regulated manufacturing environment.

+ Previous experience working on the pharmaceutical manufacturing floor under GMP conditions.

+ At least 2 years of technical writing experience focused on investigations related to manufacturing processes such as filling, formulation, and packaging.

+ Strong experience conducting deviation investigations in a regulated manufacturing setting.

+ Proven expertise in root cause analysis (RCA) using systematic problem-solving tools such as 5 Whys, 6M, and Fishbone (Ishikawa) diagrams.

+ Demonstrated experience with CAPA management, including development, implementation, and follow-up on effectiveness.

+ Excellent technical writing and documentation skills, with the ability to produce clear, concise, and compliant investigation reports.

+ Solid knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and relevant regulatory requirements.

Additional

Skills & Qualifications

+

Experience with aseptic or sterile manufacturing, filling operations, or biologics production.

+ Familiarity with electronic quality systems such as Track Wise, Veeva, SAP, or ETQ.

+ Six Sigma or Lean certification, or formal training in root cause analysis methodologies.

+ Experience supporting internal or external audits and regulatory inspections.

+ Six Sigma qualification noted as a strong asset.

+ Ability to collaborate effectively with cross-functional teams and manufacturing floor personnel.

+ Strong analytical, critical thinking, and problem-solving skills with a focus on continuous improvement.

+ High attention to detail and strong organizational skills to manage multiple investigations and deadlines.

Work Environment

This is an on-site role based in Wilson, North Carolina. The position follows Monday through Friday standard business hours, with some…