Technical Writer - Chemical Company SOP's

Position Overview

The Technical Writer serves as a dedicated documentation resource embedded within a GMP pharmaceutical and specialty manufacturing operation. The role exists to support the rapid growth of the site's production portfolio by authoring, revising, and routing the controlled documents that govern day-to-day manufacturing — including specifications, batch records, production tickets, and operating procedures.
The position has become a critical enabler of on-time batch execution. Since the role was established, instances of batch delays caused by documentation gaps have dropped significantly. The Technical Writer acts as a key point of contact for Regulus document routing and partners closely with Operations, Quality, and Regulatory stakeholders to ensure all controlled documents are drafted, reviewed, and approved well in advance of scheduled batches.
This individual is a hands-on, detail-oriented contributor who can independently navigate change control workflows, translate technical input from operators and engineers into clear procedural language, and support continuous-improvement initiatives that reduce errors, ambiguity, and unnecessary jargon in production documentation.

Essential Duties & Responsibilities

Specification & Batch Record Authoring

• Address anomalies with LACTEL specifications as they transfer into the LPF-QA templates and systems.
• Draft and route Glucose Star Polymer child specifications and other product family specifications through full review and approval.
• Author new batch records to support system transfers and product onboarding.
• Support batch transfers across equipment scales (e.g., 10-gallon to 65CV or 8CV) for GMP production.
• Document and process specifications for products that have been ordered but were not part of the original transfer plan, including LACTEL items and raw materials that cannot be released due to system differences.

Change Control & Document Routing

• Draft, review, and shepherd change controls through approval prior to any specification or ticket change being routed in Regulus.
• Serve as a key point of contact for Regulus document routing, tracking documents through review and approval cycles.
• Operate as an active TrackWise user, managing change control records and associated workflows.
• Handle deviation actions associated with production record clarity, ensuring root causes are accurately captured and corrective documentation is updated.

Production Ticket & Procedure Improvement

• Support Kaizen and Kaikaku style ticket formatting and styling initiatives across the operation.
• Identify and improve ticket flow to enhance operator clarity and execution efficiency.
• Eliminate historically tolerated but minor clerical errors that compound across batches.
• Eliminate confusing or confounding instructions and reduce unnecessary technical jargon in production documents.
• Provide drafting support to Operations as procedural updates are identified by floor staff.

Batch Preparedness & Cross-Functional Support

• Serve as an active member of batch preparedness reviews, ensuring all involved parties clear document reviews and approvals well in advance of scheduled batch execution.
• Coordinate with Operations, Quality Assurance, Regulatory, and Engineering teams to surface and resolve document gaps before they impact production.
• Maintain accurate records and version control across all assigned documents.
• Perform other related duties as assigned in support of site documentation needs.

Required Qualifications

Experience

• Three (3) or more years of technical writing experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or specialty chemical).
• Demonstrated experience authoring and revising GMP-controlled documents — specifications, batch records, SOPs, and production tickets.
• Hands-on experience with change control processes, including drafting and routing change controls through approval.

Systems & Tools

• Active working knowledge of TrackWise (or comparable QMS / change control platform).
• Experience with Regulus or similar document management and routing systems is strongly preferred.
• Proficiency with Microsoft Word, Excel, and document templating tools.

Core Competencies

• Strong written communication skills with the ability to translate complex technical input into clear, executable procedural language.
• High attention to detail and a systematic approach to managing concurrent document workflows.
• Familiarity with continuous improvement methodologies (Kaizen, Kaikaku) and their application to documentation systems.
• Self-directed and capable of operating independently across multiple stakeholder groups.
• Strong interpersonal skills suited to coordinating with Operations, QA, Regulatory, and Engineering teams.

Education

• Bachelor's degree in a technical, scientific, or communications discipline preferred; equivalent experience in a regulated manufacturing setting will be considered.

Work Arrangement

• Location: Birmingham, Alabama.
• Schedule: Hybrid — three (3) days on-site per week, two (2) days remote.
• Engagement Type: Full-time.

Interview Process

• One (1) in-person interview at the Birmingham site.

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.