Introduction

At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life-changing medicines to patients. We are seeking a Quality Specialist I to join our team Quakertown, PA. As a Quality Specialist I, you’ll be joining a fast-paced, driven environment that’s helping to make life-changing differences to patients by identifying process improvement opportunities, contributing to the development of training materials, and providing audit and inspection support. Through collaboration and diversity of teams, the Quality Specialist I is provided with multiple opportunities to excel and discover where your skills can take you.

Who we’re looking for

• Communicative individual with excellent interpersonal, verbal, and written communication.
• Reliable contributor with the ability to take initiative and have a flexible approach to work assignments and new learning.
• Critical thinker with a client focused mindset.
• Multi-tasker that will manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills.
• You are able to work independently and also as part of a team.

What you’ll do

• Execute quality checks of medicinal products and other quality critical clinical trial supplies during receipt, production, and distribution.
• Perform quality control tasks in depot and warehouse operations, as assigned.
• Undertake local quality management tasks as described in Parexel controlled documents.
• Provide support for change control management related to premises, equipment, and processes, including depot and warehouse environments.
• Support premise and equipment (P&E) maintenance and cleaning.
• Undertake local P&E quality tasks as defined in Parexel procedures to cover local QA tasks.
• Perform reviews of Production Batch Records.
• Perform and support P&E qualification and validation activities.
• Participate in SOP and process development.
• Serve as a quality consultant to designated operational group(s), including process authoring and review, process re-engineering support, provision of GxP and process expertise, contribution to the development of training materials as a process subject matter expert, support for identification, management, and prevention of quality issues, audit and inspection support, and assistance with the collection and reporting of quality metrics, as assigned.
• Provide quality consultancy to operations personnel.
• Verify compliance with GxP guidelines, local regulations, protocol, Parexel procedures and/or sponsor requirements.
• Remain informed about developments in relevant regulations and guidelines.

Additional Details

• Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred.
• Experience of working a minimum of one year in a GMP environment.
• Must be educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or have equivalent years’ experience.
• This is an in-person position at Parexel's North America Distribution Center located in Quakertown, PA.

Why join us

• Be part of groundbreaking projects that are pushing the boundaries of the industry.
• Experience a collaborative and inclusive work environment that appreciates your expertise.
• Unlock your full potential with professional growth and development opportunities.

Parexel US Benefits

• All benefits are effective on the first day of employment.
• Health, Vision & Dental Insurance
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• Full list of benefits available here: https://www.parexel.com/us-benefits

If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!

At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, and you’re exposed to a world of experiences and open doors.