Quality Specialist I – Logistics & GMP Compliance

Parexel International; Quakertown (Bucks County); On-site; USD 33,000 - 45,000; 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 for an on-site role at the North America Distribution Center in Quakertown, PA. You will support quality operations across receipt, storage, and distribution, ensuring regulatory compliance and product quality.

You will collaborate with cross-functional teams and contribute to process improvements and training materials. Requirements include a bachelor’s degree in a health-related field or equivalent experience, and at least 1 year in a GMP environment

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

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 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.

Skills

Interpersonal skills

Communication

Initiative

Critical thinking

Organization

Teamwork

Education

Bachelor's degree in life sciences

Tools

Quality Management Systems

Job description

Parexel is seeking a Quality Specialist I for an on-site role at the North America Distribution Center in Quakertown, PA. You will support quality operations across receipt, storage, and distribution, ensuring regulatory compliance and product quality.

You will collaborate with cross-functional teams and contribute to process improvements and training materials. Requirements include a bachelor’s degree in a health-related field or equivalent experience, and at least 1 year in a GMP environment