Quality Control Investigations Specialist

Piper Companies is seeking an Quality Control Investigations Specialist to join a global leader in vaccine and pharmaceutical manufacturing in Lansdale, PA.

Responsibilities of the Investigations Specialist:

•       Conduct detailed trend analysis for a variety of virology-based assays

•       Generate and maintain accurate documentation to record results and assess potential changes

•       Support process improvement initiatives, including the standardization and execution of test methods and assay validation/qualification

•       Lead and participate in OOS (Out of Specification) and Deviation Investigations, occasionally performing hands-on experiments in support of root cause analysis

•       Ensure all activities remain compliant with regulatory standards, internal guidelines, and SOPs

Qualifications of the Investigations Specialist:

•       Minimum of 2 years of experience in a Laboratory or Pharmaceutical Manufacturing environment (preferred)

•       Hands-on experience with deviation investigations, and root cause analysis

•       Exposure to or interest in process improvement initiatives

•       Strong technical writing abilities

•       Bachelor’s degree in Biochemistry or a related scientific discipline

Compensation for the Investigations Specialist

·       Salary Range is Commensurate with Experience

·       Long Term Contract (Possible Extension)

·       Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays

This job opens for applications on 5/5/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

Virology, Investigations, OOS, Deviation, Assay Trending, Root Cause Analysis, Technical Writing, CAPA, Process Improvement, Biochemistry, GMP, SOP, Assay Validation, Assay Qualification, Laboratory Compliance, Pharmaceutical Manufacturing, Quality Systems, Documentation Control, Data Analysis, Regulatory Compliance

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