Part-Time Quality Specialist I - 2nd Shift

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 distributionProviding support for Change Control management related to premises, equipment and processes in depots/warehousesSupporting premise and equipment (P&E) maintenance and cleaningUndertaking local P&E Quality tasks as defined in Parexel procedures to cover local QA tasksPerforming review of Production Batch RecordsPerforming and supporting P&E qualification/validation activitiesOther Activities:Identifying process improvement opportunities and champion their implementationParticipating in SOP and process developmentWorking with the relevant training functions including Parexel Academy/Learning & Development and OperationsAssisting with the development or enhancement of training materialsParticipating in development of quality-related processes and toolsProviding quality consultancy to Operations personnelVerifying compliance with GxP guidelines, local regulations, protocol, Parexel procedures and/or sponsor requirementsProviding audit and inspection supportProviding support for management of quality issuesAttending (or where required, lead) internal quality-focused meetingsMaintaining a familiarity with Parexel systems and related processes, Parexel Standard Operating Procedures and relevant regulations and guidelinesRemaining informed about developments in relevant regulations and guidelinesSharing information in an open, balanced and objective manner with other Quality Management and other Parexel professionals to maintain positive, results-oriented team environmentQualificationsYour Skills:Excellent interpersonal, verbal and written communicationClient-focused approach to workAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skillsAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationIT literate: experienced with Microsoft based applications and general knowledge of personal computer functionsAbility to think and work globally and be culturally awareWritten and oral English proficiencyYour Profile:Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experienceRelevant 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 preferredKnowledge of GxP regulations, preferredTraining experience, as appropriate, preferredAbility to work 2nd shift (4pm-1am)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 DisclaimerParexel 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.