Job Title: QA Investigations Writer

Work Location: Bucks County, Pennsylvania

Summary:

The QA Investigations Writer is responsible for supporting quality systems by investigating quality events and maintaining controlled documentation within a regulated manufacturing environment. This role ensures all documentation and investigations are compliant with current Good Manufacturing Practices (cGMP) and regulatory standards, while collaborating with cross-functional teams to drive continuous improvement.

Responsibilities:

• Conduct and document investigations for quality events, including deviations, incidents, out-of-specification results, and customer complaints.
• Perform root cause analyses and develop corrective and preventive actions (CAPAs) in accordance with regulatory requirements.
• Draft, revise, and maintain controlled documents such as standard operating procedures, batch records, validation protocols, and technical reports.
• Support change control processes related to manufacturing, equipment, facilities, and quality systems.
• Collaborate with various departments to ensure documentation accuracy and alignment with procedures.
• Contribute to continuous improvement initiatives by analyzing trends and supporting quality system enhancements.
• Ensure all quality documentation meets compliance standards and regulatory expectations.
• Participate in audits and respond to audit observations as needed to support site quality objectives.

Qualifications:

• Bachelor’s degree in a scientific or technical field such as Chemistry, Biology, Pharmacy, or Engineering required; Master’s degree preferred.
• Minimum of 3 years of experience in a pharmaceutical or regulated manufacturing environment.
• Proven experience in technical writing, deviation and CAPA management, and change control systems.
• Strong knowledge of cGMP requirements and FDA quality system regulations.
• Excellent written communication, analytical, and organizational skills with high attention to detail.

Published Category: Quality & Validation