Job Title: Technical Writer - GxP Investigation Specialist

Location: Cambridge, MA (Hybrid)

Hourly Pay: $59

Job Summary:

The Technical Writer is responsible for managing GxP investigation activities, owning and authoring deviation investigation reports, revising and writing procedures, and acting as the document coordinator for the Facilities, Engineering, and Validation (FEV) department. This role requires strong technical writing skills, collaboration with cross-functional teams, and a deep understanding of regulatory compliance to ensure the integrity of processes and documentation.

Key Responsibilities:

Authoring and Reviewing Documents:

• Update, author, and review FEV standard operating procedures (SOPs) and other controlled documents based on process improvements, CAPAs, and gap assessments.

Investigation Activities:

• Perform GxP investigation activities and write clear, concise, and accurate deviation investigation reports for the FEV department.
• Collaborate with subject matter experts (SMEs) from various departments to complete cross-functional evaluations and align GxP practices.
• Utilize root cause analysis tools to determine the root cause of GxP deviations and assist in impact analysis and corrective action identification.

CAPA and Change Control Management:

• Participate in defining appropriate corrective and preventative actions (CAPAs) after investigations.
• Initiate and manage change controls as needed for Engineering and Facilities operations.

Process Improvements:

• Identify opportunities for continuous process improvements and coordinate prompt evaluation, investigation, and closure of discrepancies in processes or equipment.

Documentation Coordination:

• Manage the lifecycle of Facilities Engineering GMP documents as the document coordinator, ensuring compliance with quality standards and regulations.

Education and Experience Requirements:

Educational Qualifications:

• Bachelor's degree, preferably in a scientific or engineering discipline (e.g., Biology, Chemistry, Engineering).

Experience:

• Minimum of 3-5 years of experience in the pharmaceutical or a regulated industry, preferably in a GxP environment.
• Proven experience with troubleshooting, investigations, and root-cause analysis for equipment-related issues.
• Strong technical writing skills with the ability to effectively communicate complex technical events in a concise and accurate manner.

Technical Expertise:

• Demonstrated understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing/packaging processes.
• Working knowledge of SAP or similar deviation management systems and Veeva or equivalent quality document systems.

Skills and Abilities:

• Exceptional analytical and problem-solving skills with the ability to work independently and in a cross-functional team environment.
• Ability to manage multiple priorities effectively while maintaining attention to detail and quality standards.

Preferred Qualifications:

• Advanced proficiency in quality systems and compliance practices.
• Strong facilitation skills to drive cross-departmental alignment during investigations and process improvement discussions.