Job Title: Technical Writer

Job Description

The role of Technical Writer involves developing, reviewing, and maintaining technical documents related to Analytical Research and Development (ARD) and Quality Control (QC) operations. You will ensure compliance with regulatory guidelines, including FDA, ICH, USP, EP, and cGMP, as well as company in-house standards. This position requires strong collaboration with QC analysts, scientists, and Quality Assurance teams to produce clear, accurate, and well-structured documentation.

Responsibilities

• Write, edit, and maintain Standard Operating Procedures (SOPs), test methods, specifications, work instructions, and protocols related to Quality Control and Analytical Development.
• Develop and update analytical test reports, Certificates of Analysis (COA), validation protocols (IQ/OQ/PQ), and stability study reports.
• Prepare method validation protocols/reports, method transfer protocols/reports, and technical documents, including change controls, deviations, CAPAs, and OOS (Out of Specification) and laboratory investigations.
• Ensure consistency, clarity, and compliance in all documentation.
• Maintain up-to-date copies of all cGMP documents in the laboratory and relevant databases.
• Ensure all QC documentation aligns with regulatory guidelines such as FDA, ICH, USP, EP, and cGMP.
• Assist in preparing documentation for regulatory submissions and audits, both internal and external.
• Maintain accurate version control and document tracking within electronic document management systems (ACE).
• Collaborate closely with QC analysts, outside contract testing laboratories, customers, equipment manufacturers, and Quality Assurance to gather technical information.
• Assist in reviewing and updating documents based on feedback from Quality Assurance (QA) and customers.
• Provide guidance to QC personnel on documentation best practices and compliance requirements.
• Develop training materials for QC team members on updated SOPs, specifications, and test methods.
• Support quality improvement initiatives by identifying gaps in documentation and recommending improvements.
• Stay updated with industry best practices, regulatory changes, and advancements in pharmaceutical quality control.

Essential Skills

• Degree in Chemistry or Chemical Engineering.
• 2-3 years of analytical testing using techniques such as HPLC, Dissolution, GC, FTIR, KF, UV VIS with method development, validations, and transfers.
• 2-3 years of technical writing experience preparing method validation reports, method transfer reports, change controls, specifications, and protocols.
• Solid oral dosage and pharmaceutical GMP experience.

Additional Skills & Qualifications

• Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biotechnology, or a related field.
• 2-5 years of experience in technical writing within the pharmaceutical or biotech industry, preferably in Quality Control/Analytical Development.
• Strong understanding of analytical techniques and laboratory procedures.
• Familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP.
• Excellent writing, editing, and organizational skills.
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Strong attention to detail and ability to translate complex scientific information into clear documentation.
• Ability to work independently and collaborate effectively with cross-functional teams.

Work Environment

The role will be based in a laboratory setting, working with a team of approximately 10 people. The environment is dynamic, supporting a growing Contract Manufacturing Organization (CMO) with high pay and a new facility.