When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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.
- 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.
- 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.
- 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.
- 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.
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.
Skills Required
- Relevant experience in Clinical Research, Logistics Quality Management support preferred
- Minimum one year in a GMP environment
- Educated to degree level in technology, biological science, pharmacy or health related discipline
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
