QA Investigator/Technical Writer

Job Title: Investigation and Deviation Writer

Job Description

We are seeking a dedicated Investigation and Deviation Writer responsible for writing and completing investigations and deviations from a compliance and operations perspective. This role involves conducting root cause analyses and managing the full lifecycle of investigations, from initiation to closure, to ensure manufacturing and GMP compliance.

Responsibilities

• Determine the causes and preventative actions of Deviations, Non-Conformances, Out-of-Specification (OOS), Out-of-Trend (OOT), field complaints, and environmental excursion investigations.
• Drive investigations to uncover true root causes using appropriate tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track Corrective and Preventative Action (CAPA) plans.
• Identify and create appropriate 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 to educate personnel on writing problem statements and using root cause analysis tools.
• Champion CAPA plans and implementation.
• Provide ongoing communication plans for deviations and CAPAs.
• Oversee timely completion of deviations, CAPAs, and Change Controls.
• Ensure adherence to quality standards.

Essential Skills

• 2-3 years of experience writing and reviewing deviations and investigations within a pharmaceutical company.
• Experience working with quality assurance teams to ensure accurate tracking and documentation of investigations.
• Proficiency in root cause analysis, CAPA, and biologics.
• Experience with GMP operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
• Familiarity with e-Quality Management Systems.

Additional Skills & Qualifications

• Bachelor's degree in a related scientific field.
• Experience in technical writing.
• Experience with cell and gene therapies or biologics.
• Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.

Work Environment

You will work closely with a team of QA/QC professionals in a collaborative environment, engaging cross-functionally with the manufacturing team. The role involves working at two sites located close to each other. The team consists of five other investigators, and you will work the first shift from Monday through Friday, starting between 8 AM and 9 AM. The company offers a supportive work culture with opportunities for growth and expansion, as well as the satisfaction of contributing to saving patients' lives.