Quality Specialist I Logistics

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. 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.

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

Qualifications

Required:

• 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:

• 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

Skills

• 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

Benefits

• 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.

Pay

The potential base hourly pay range for this role is $24/hr to $33/hr. 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.