Non-IT - PA - West Point, PA
West Point, Pennsylvania
Locations: West Point, King of Prussia, Lansdale, Philadelphia
Posted On:
July 08, 2025
Last Day to Apply:
July 29, 2025
Pay:
$41.00 per hour
Title: Pharmaceutical Quality Investigator Duration: 12 Months Location: West Point, PA
Rate: $41.00/hr on W2
Qualifications:
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.
Responsibilities:
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.
