Quality Specialist I Logistics

Parexel International; Quakertown (Bucks County); On-site; USD 68,770,000 - 94,558,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Quality Specialist I to join our North America Distribution Center team in Quakertown, PA. You will support quality operations, conduct quality checks on medicinal products, ensure GMP compliance, and advise on GxP practices throughout receipt to distribution.

This on-site role offers growth in regulatory excellence, collaboration with cross-functional groups, and opportunities to contribute to process improvements.

Qualifications

• Bachelor's degree in technology, biological science, pharmacy, or health-related discipline.
• Minimum 1 year GMP environment experience.
• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
• Experience with quality management systems and processes in clinical/pharma setting.
• Strong communication, organization, and problem-solving skills.

Responsibilities

• Execute quality checks of medicinal products and 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.
• Support premise and equipment maintenance and cleaning activities.
• Perform reviews of Production Batch Records and support qualification and validation activities.
• Participate in SOP and process development initiatives.
• Serve as a quality consultant to operational groups, including process authoring, review, and expertise in GxP guidelines.
• Contribute to the development of training materials as a process SME.
• Support identification, management, and prevention of quality issues through audit and inspection support.
• Provide quality consultancy to operations personnel and verify compliance with GxP guidelines and regulations.

Skills

Quality assurance

GxP compliance

Regulatory knowledge

Communication skills

Problem-solving

Education

Bachelor's degree in technology, biological science, pharmacy, or health-related discipline

Tools

Quality Management System (QMS)

GxP documentation

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Quality Specialist I to join our team in an on-site capacity at our North America Distribution Center in Quakertown, PA. As a Quality Specialist I, you will support quality operations that help bring life-changing medicines to patients. This position plays a key role in quality assurance, regulatory compliance, and clinical supply chain integrity. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to quality operations from receipt through distribution. Responsibilities include executing quality checks on medicinal products, performing quality control tasks in depot and warehouse operations, and providing quality consultancy to operations personnel.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through quality assurance, process improvement, and regulatory excellence. With diverse teams and continuous learning opportunities, the Quality Specialist I can explore career paths and expand skills across clinical research and supply chain operations.

Key Responsibilities

• Execute quality checks of medicinal products and 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


• Support premise and equipment maintenance and cleaning activities


• Perform reviews of Production Batch Records and support qualification and validation activities


• Participate in Standard Operating Procedure (SOP) and process development initiatives


• Serve as a quality consultant to operational groups, including process authoring, review, and expertise in GxP guidelines


• Contribute to the development of training materials as a process subject matter expert


• Support identification, management, and prevention of quality issues through audit and inspection support


• Provide quality consultancy to operations personnel and verify compliance with GxP guidelines and regulations

Candidate Profile

You’ll thrive in this role if you bring:

• Excellent interpersonal, verbal, and written communication skills


• Ability to take initiative with a flexible approach to work assignments and new learning


• Critical thinking with a patient and client-focused mindset


• Strong organizational skills with the ability to manage multiple and varied tasks with attention to detail


• Capability to work independently and collaboratively as part of a team


• Attention to quality and compliance in a regulated environment

Required Qualifications

• Bachelor's degree in technology, biological science, pharmacy, or other health-related discipline, or equivalent years of professional experience


• Minimum 1 year of experience in a GMP (Good Manufacturing Practice) environment


• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes


• Experience with quality management systems and processes in a clinical or pharmaceutical setting


• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Experience in clinical research, pharmaceutical industry, or Clinical Research Organization (CRO) environments


• Familiarity with Logistics Quality Management (LQM) support functions


• Experience with quality management systems and documentation


• Background in depot, warehouse, or supply chain quality operations

Benefits and Compensation

• Health, Vision & Dental Insurance


• Tuition Reimbursement


• Vacation/Holiday/Sick Time


• Flexible Spending & Health Savings Accounts


• Work/Life Balance


• 401(k) with Company match


• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

The potential base hourly pay range for this role is $24hr to $33hr. The actual hourly salary pay offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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.