What are the responsibilities and job description for the Pharmaceutical Quality Investigator - PQI 0312 VG#01 position at NavitsPartners?
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.
Salary : $41
