GMP Quality Investigator
: Job Details :

One of our large pharmaceutical clients is seeking a Quality Investigator to join their growing team in Malvern, PA. This Investigator supports the overall QC organization and is responsible for authoring nonconformance investigations, corrective and preventative action records, document management, assay trending, root cause problem solving, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and strong technical writing skills. This position will drive improvements within a global organizational framework and will start off as fully onsite for the first 2 months of training and then can move into a hybrid schedule of 3 days onsite & 2 days remote. Other responsibilities include:

• Performs and documents all QC investigations (non-conformance, deviations, invalid assays)
• Authors and executes corrective and preventative action record and execute CAPAs when required for the Quality Control organization
• Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified
• Manages change through chance control process and support internal and external audits
• May performs Gap Assessments for local QC documents against new standards and other quality documents
• Reports data from QC as required for the site management review
• Support Health Authority inspections and provide input to functional laboratory meetings
• Make decisions as a QC representative at cross-functional meetings and provide leadership and insight as a member of global project teams

Qualifications:

• Minimum of a Bachelor's Degree
• Minimum of 2-4 years of related GMP investigation and/or technical writing experience
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required

Salary: $80,000-$104,000 (flexible based on experience)

Hours: Monday-Friday, 9:00am-4:00pm

Hiring Method: 1 year-long contract with the high likelihood of extension and opportunity for permanent hire

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

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.