Pharmaceutical Quality Investigator - PQI 0312 VG#01

Title: Pharmaceutical Quality Investigator

Duration: 12 Months

Location: West Point, PA

Rate: $41.00/hr on W2

Education Requirements:

• B.S. or B.A. in Engineering, Sciences, or a related discipline.
• 2-4 years of experience (including co-op or real-world experience).

Required Experience and Skills:

• Strong technical writing skills.
• Highly developed communication, leadership, and teamwork skills.
• Ability to manage projects and meet deadlines.

Preferred Experience and Skills:

• Experience in biologics, vaccines, or bulk sterile manufacturing facilities.
• Change Control experience.
• Deviation Management and Investigation experience.

• Author, support, update, and/or lead documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents, and other GMP documentation.
• Support deviation investigations, including assessing product impact, determining root causes, and developing corrective/preventative actions.
• Assist in writing investigations and quality incident reports.
• Support equipment and facility projects across various Sterile Supply Departments.
• Contribute to continuous improvement initiatives that enhance compliance, reduce costs, and simplify/standardize processes.
• Analyze complex issues from multiple perspectives (safety, compliance, automation, equipment, process, and personnel) to determine and resolve root causes.
• Design, conduct, and review experimental protocols as needed.
• Provide on-the-floor support for operational and technical (process/equipment) issues.
• Lead and execute projects to improve process performance, including:
  • Corrective/Preventative Actions (CAPAs).
  • Right-First-Time initiatives to prevent/reduce deviations.
  • Efficiency, cost-reduction, and compliance improvement projects.
• Support team safety, environmental, and compliance goals.
• Manage project timelines to meet compliance and customer deadlines, escalating potential delays and developing remediation plans when needed.
• Collaborate effectively with Operations, Quality, Planning, project teams, and external vendors.