Senior Compliance Specialist

One of our large pharmaceutical clients is seeking a Senior Compliance Specialist to join their growing team in Malvern, PA. This person will be responsible for supporting audits, 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 written and verbal communication skills.

Responsibilities

-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

Requirements:

-Minimum of a Bachelor's Degree in a scientific discipline

-Minimum of 5 years of related GMP investigation and/or compliance experience in the pharmaceutical/life sciences industry

-Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems

Compensation:

$35hr to $43/hr.

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.