Job Description

One of our large pharmaceutical clients in Spring House, PA is seeking an Investigator to join their growing team supporting the Cell Therapy Development organization within R&D. This person will be responsible for driving nonconformance investigations end-to-end, including root cause analysis, risk analysis, creating and owning corrective action plans, and updating procedures accordingly. This position requires analytical thinking, organizational leadership, and strong written and verbal communication skills. Responsibilities include:

• Independently run investigations (non-conformance, deviations, invalid assays)
• Author and execute corrective and preventative action record and execute CAPAs
• Track deviations and provide reports to management on trending as it relates to assigned investigations
• Identify gaps in processes or systems based on current and future regulatory requirements and communicate necessary changes to leadership and appropriate stakeholders
• Manage change through change control process and support internal and external audits
• Keep track of regulatory requirements and changes and perform Gap Assessments as needed

Qualifications:

• Minimum of a Bachelor's Degree in a scientific discipline
• 5+ years of related investigation experience in a GMP laboratory
• Experience conducting end to end investigations and defining corrective action plans
• Knowledge and understanding of current Good Manufacturing Practices (cGMP)

Salary: $45.00-$65.00/hr (can be flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm

Hybrid Schedule: 3 days onsite & 2 days remote a week

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO : 10 PTO days, 6 paid sick days annually & paid Holidays

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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