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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Quality Specialist I - 2nd Shift

Job ID 77303BR Quakertown, Pennsylvania
Parexel is looking for a Quality Specialist I to perform Quality Control tasks in depot and warehouse operations in our North America Distribution Center (NADC), located in Quakertown, PA. This role undertakes local quality management tasks as described in Parexel controlled documents. As a Quality Specialist I, you will serve as a quality consultant to the designated operational groups by identifying process improvement opportunities, contributing to the development of training materials, providing audit and inspection support and more!

Day to Day Activities:
  • Executing quality checks Execute QC checks of Medicinal Products and other quality critical Clinical Trial Supplies during receipt, production and distribution
  • Providing support for Change Control management related to premises, equipment and processes in depots/warehouses
  • Supporting premise and equipment (P&E) maintenance and cleaning
  • Undertaking local P&E Quality tasks as defined in Parexel procedures to cover local QA tasks
  • Performing review of Production Batch Records
  • Performing and supporting P&E qualification/validation activities
Other Activities:
  • Identifying process improvement opportunities and champion their implementation
  • Participating in SOP and process development
  • Working with the relevant training functions including Parexel Academy/Learning & Development and Operations
  • Assisting with the development or enhancement of training materials
  • Participating in development of quality-related processes and tools
  • Providing quality consultancy to Operations personnel
  • Verifying compliance with GxP guidelines, local regulations, protocol, Parexel procedures and/or sponsor requirements
  • Providing audit and inspection support
  • Providing support for management of quality issues
  • Attending (or where required, lead) internal quality-focused meetings
  • Maintaining a familiarity with Parexel systems and related processes, Parexel Standard Operating Procedures and relevant regulations and guidelines
  • Remaining informed about developments in relevant regulations and guidelines
  • Sharing information in an open, balanced and objective manner with other Quality Management and other Parexel professionals to maintain positive, results-oriented team environment


Your Skills:
  • Excellent interpersonal, verbal and written communication
  • Client-focused approach to work
  • Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills
  • Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
  • IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
  • Ability to think and work globally and be culturally aware
  • Written and oral English proficiency
Your Profile:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience
  • 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
  • Knowledge of GxP regulations, preferred
  • Training experience, as appropriate, preferred
This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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