Job Description

Job Summary:

CONTRACT POSITION - This position is responsible for bringing expertise in developing, reviewing, and managing technical documents to support pharmaceutical manufacturing operations.This role is essential for ensuring that all written materials comply with GMP, FDA, and DEA guidelines, with clear direction to address complex process and regulatory requirements to internal teams and external stakeholders. The ideal candidate will have experience with process mapping, root cause analysis, risk assessments, and quality system documentation. This role seeks to enhance cross-functional collaboration and knowledge transfer.

Essential Functions:

• Develop, revise, and maintain Standard Operating Procedures (SOPs), deviations, CAPAs, batch records, change controls, and protocols.
• Translate technical and scientific information into clear, compliant documentation.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and other cross functional teams to drive problem solving and source material.
• Perform and maintain document control systems and revision tracking.
• Participates in investigations and deviations; assists in assigning root cause and the implementation of corrective and preventive actions (CAPA)
• Support CAPA, deviation, and change control documentation processes; perform line side problem solving for quick deviation documentation and resolution.
• Ensure all documentation aligns with GxP standards and internal quality systems.
• Provides communication within and between all shifts, departments, and levels of the company as needed.
• Assist with SOP training and provide guidance and training to staff members when there are revisions to SOPs.
• Utilize electronic document management system (Veeva), to manage approval workflow.
• Review technical content for clarity, accuracy, and compliance with company style guidelines.
• Develops and supports faster product release cycles through accurate and timely documentation.
• Proven experience producing documentation that passes audits with minimal findings.

Additional Responsibilities:

Perform other duties and responsibilities, as assigned.

Job Specifications:

• Bachelor’s degree (or equivalent) preferred in Life Sciences, Pharmacy, Chemistry or related field
• 2+ years’ experience as a Technical Writer in the GMP-regulated environment preferred.
• Experience in a cGMP Pharmaceutical manufacturing environment preferred.
• Strong understanding of pharmaceutical manufacturing processes, including ISO classification.
• Familiarity with FDA and DEA documentation requirements
• Knowledge of MS Word, MS Excel, and MS SharePoint. Proficiency in MS Excel preferred.
• Proficiency with document management systems (Veeva, Trackwise strongly preferred)
• Possesses excellent written/verbal communication and organizational skills.
• Conducts activities with professionalism and treats all associates with respect.
• Possesses a good understanding of manufacturing operations/systems and related processes.
• Requires the ability to work independently, with minimal supervision.
• Possesses good written and verbal communication skills.
• Ability to write SOPs (Standard Operating Procedures), incidents, deviations and change controls as needed.
• Comprehend and follow written procedures (batch records, operating procedures, protocols).
• Experience with Lean Principles and 6S preferred.

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