Compensation & Notes:

• Onsite in Malvern, PA - Hybrid 3 days onsite, 2 days remote.
• 12 month extending contract
• PTO & Sick Time built into contract
• $41-$47/hr - Exact compensation may vary based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 1st 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

Qualifications :

• Bachelor Degree in Science or related field
• At least 5 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience. -Experience with risk assessment processes.
• Knowledge of global GMP regulations is required.
• Strong analytical skills. Ability to clearly articulate issues.
• Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community.
• Delivers on commitment timelines and has high sense of urgency.

Day-to-Day: One of our large pharmaceutical clients is looking to hire a Compliance Specialist to join their Quality Assurance team in Malvern, PA. This individual will be preparing for and supporting external GMP audits and inspections for the Health Authority, Customer, ERC, etc. Additionally, they will be providing compliance subject matter expertise to the manufacturing sites and site-based projects.

Responsibilities will include:

• Support external GMP audits and inspections
• Review site response and associated CAPA for Health Authority inspections.
• Support internal and external audit preparation and execution for the Malvern JSC site.
• Accurate Quality Review of Quality Agreements ensuring compliance to local and global procedures. Coordinate review by stakeholders.
• Coordinate Gap Assessment process at the site. Coordinate SME gap assessments, track updates required at a local level.
• Complete required documentation based on the assessments following global procedures.
• Schedule, run, and participate in mock recall activities including the facilitation of any meetings and follow-up as the process completes.
• Assist in compiling of information for the Site Quality Risk Register.
• Update presentations and assist with gathering information.
• Assist in writing and editing procedures and quality investigations
• Assist in compiling the Site Master File, coordinate SME updates and reviews, final document compilation

Training:

• Facilitate the asynchronous Train the Trainer module by grading submittals and providing guidance/feedback to trainees.
• Edit training modules
• Create courses in SUMMIT