Job Title: Technical Writer Compliance

Job Description

We are seeking a skilled Technical Writer Compliance professional who will be responsible for writing and completing investigations and deviations from both compliance and operations perspectives. The role involves reviewing investigations and deviations to ensure manufacturing and GMP compliance, conducting root cause analysis, and managing the entire lifecycle of an investigation independently. This position requires excellent technical writing skills and effective communication as you will be interviewing manufacturing personnel and speaking with vendors regarding investigations.

Responsibilities

• Determine the causes and preventative actions for Deviations, Non-Conformances, OOS, OOT, field complaints, and environmental excursion investigations.
• Drive investigations to true root cause using appropriate tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages to meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track CAPA plans.
• Identify and create trending rules that trigger corrective actions.
• Analyze process data and evaluate trends to identify major improvement opportunities.
• Utilize change management approaches effectively.
• Develop training materials for personnel on writing problem statements and using root cause analysis tools.
• Champion CAPA plans and implementation.
• Provide communication plans for ongoing deviations and CAPAs.
• Create and communicate CAPA plans to responsible parties.
• Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
• Abide by quality standards.

Essential Skills

• Compliance expertise
• Aseptic technique knowledge
• Root cause analysis proficiency
• Strong technical writing skills
• Experience in writing deviations and CAPAs
• 3-5 years of experience in writing and reviewing deviations and investigations
• 3-5 years of experience in a pharma company supporting manufacturing
• Previous quality assurance team experience

Additional Skills & Qualifications

• Bachelor's degree in a related scientific field
• Experience in GMP Operations or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma
• Preferred experience in pharmaceutical or FDA regulated operations
• Experience using e-Quality Management Systems
• Proficiency with IT skills, including Visio, Microsoft Project, and Excel
• CAPA experience
• Previous experience with cell and gene or biologics

This position is urgently hiring. If interested, please submit your most updated resume and email your availability over for a 5-10 minute call to kvespia @astoncarter.com