Quality Assurance Specialist

Piper Companies is seeking a Quality Assurance Specialist to join a cutting-edge company that produces medicines, vaccines and biologic therapies. This position is located in West Point, Pennsylvania. The Clinical Supplies Quality Specialist position revolves around detailed working of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications.

Responsibilities of the Quality Assurance Specialist include:

·      Evaluation and disposition of clinical supplies with assurance of following government regulations. Along with coordination of preparation of procedures and processes and quality improvements

·      Assist in coordinating significant quality events including fact finding and investigation support

·      Collaborate across IPT functional and business areas to ensure continuous improvement

·      Actively using and championing the use of Lean Six Sigma (LSS) and production system- both used in day-to-day operational tasks

Qualifications for the Quality Assurance Specialist include:

·      Minimum 2 years’ experience in Pharmaceutical or industry Good Manufacturing Practice, or related field such as, engineering, quality or operations

·      Familiarity with batch disposition activities

·      Strong written and verbal communication skills, problem-solving skills, and demonstrated ability to work independently as well as in a team environment

·      Attnetion to detail, flexibility, and awareness of production and quality control problems

·      Bachelor's degree in engineering, science or related field

Compensation for the Quality Assurance Specialist include:

·      Pay Rate: $33-$43/hr.

·      Hybrid work schedule

·      Long-term contract (with strong possibility of extension)

·      Comprehensive Benefits: Comprehensive Benefits: Medical, Dental, Vision, 401K, Sick Leave if required by law

This job opens for applicants on 8/18/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Quality Assurance Specialist, Quality Specialist, document review, rights and well-being of patients, data, clinical supplies, batch documentation, clinical packaging, labeling and distribution, regulatory, Investigation New Drug applications, Clinical Trial Applications, full-time, pharma, pharmaceutical manufacturing, drug manufacturing, process validation, sampling, testing

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