Technical Writer

The Individual is responsible for supporting GMP manufacturing operations through high-quality technical documentation, deviation investigation ownership, and cross-functional operational support for clinical and/or commercial drug product manufacturing.

This role is responsible for authoring, reviewing, and managing deviations, CAPAs, technical reports, SOPs, batch record updates, and manufacturing documentation to ensure compliance with cGMP regulations, principles, and internal quality standards. The individual will partner closely with Manufacturing, Quality Assurance, MS&T, Engineering, Validation, and Supply Chain teams to support timely investigation closure, process improvements, and manufacturing readiness.

The Candidate acts as a technical resource for manufacturing documentation and quality systems by independently leading deviation investigations, performing root cause analysis, driving corrective and preventive actions, and ensuring clear, concise, and inspection-ready technical writing. This role also supports continuous improvement initiatives, operational excellence programs, and quality culture development across the manufacturing organization.

Among the technical proficiencies required, the [Contingent] Sr./Specialist must demonstrate strong investigation writing capabilities, critical thinking, data analysis, technical editing, risk assessment execution, and the ability to communicate effectively across departments while maintaining a strong floor presence and operational awareness.

Here's What You'll DoFollow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Practice and promote safe work habits and adhere to safety procedures and guidelines.

Execute tasks precisely as defined in internal procedures, Standard Operating Procedures (SOPs), and work instructions.

Follow Good Documentation Practices (GDP) and Data Integrity ) requirements to ensure documentation accuracy, completeness, and inspection readiness.

Author, revise, review, and manage manufacturing deviations, investigations, CAPAs, technical reports, and quality event documentation.

Lead deviation investigations utilizing root cause analysis tools including fishbone analysis, 5-Why methodology, and risk assessments.

Partner cross-functionally with Manufacturing, QA, MS&T, Engineering, Validation, and Supply Chain to gather investigation data and drive timely closure of quality records.

Support batch record review activities and identify documentation discrepancies, procedural gaps, and process improvements.

Author and revise SOPs, work instructions, batch production records, protocols, and technical documentation to support manufacturing operations.

Support implementation and effectiveness checks for CAPAs and continuous improvement initiatives.

Ensure deviations and technical documents are written in a clear, concise, technically accurate, and compliant manner suitable for regulatory inspection.

Track investigation metrics and support efforts to reduce deviation recurrence and improve closure timelines.

Support audit and inspection readiness activities by providing documentation support and responding to quality system inquiries.

Participate in operational excellence initiatives focused on process simplification, documentation standardization, and right-first-time execution.

Provide on-the-floor support for investigations, fact-finding activities, troubleshooting, and manufacturing assessments.

Utilize manufacturing and quality systems as required including, but not limited to, Veeva, SAP, Syncade, DeltaV, LIMS, CMMS, and Microsoft Office applications.

Support training initiatives related to deviation writing, documentation practices, and GMP compliance expectations.

The Individual is responsible for supporting GMP manufacturing operations through high-quality technical documentation, deviation investigation ownership, and cross-functional operational support for clinical and/or commercial drug product manufacturing.

This role is responsible for authoring, reviewing, and managing deviations, CAPAs, technical reports, SOPs, batch record updates, and manufacturing documentation to ensure compliance with cGMP regulations, principles, and internal quality standards. The individual will partner closely with Manufacturing, Quality Assurance, MS&T, Engineering, Validation, and Supply Chain teams to support timely investigation closure, process improvements, and manufacturing readiness.

The Candidate acts as a technical resource for manufacturing documentation and quality systems by independently leading deviation investigations, performing root cause analysis, driving corrective and preventive actions, and ensuring clear, concise, and inspection-ready technical writing. This role also supports continuous improvement initiatives,…