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Quality Assurance Specialist

2 months ago


Baltimore, Maryland, United States Piper Companies Full time

Piper Companies is seeking a highly skilled Quality Assurance Specialist to join their clinical pharmaceuticals team in a dynamic and fast-paced environment.

Key Responsibilities:

  • Establish and maintain effective communication with internal and external stakeholders, including vendors and regulatory bodies.
  • Develop and implement new Standard Operating Procedures (SOPs) and improve existing ones to ensure compliance with industry regulations.
  • Manage quality records, including deviations, change controls, CAPAs, and out-of-specification records, to ensure timely initiation, tracking, and closure.
  • Conduct thorough reviews of manufacturing batch records to ensure accuracy and compliance.

Requirements:

  • Bachelor's degree in a scientific field, such as biology, chemistry, or pharmaceutical sciences, with a minimum of 2 years of experience in quality assurance or a related field.
  • Strong understanding of regulatory requirements, including FDA guidelines and industry standards.

Benefits:

  • Competitive salary range: $70,000 - $80,000 per year.
  • Comprehensive benefits package, including medical, dental, and vision coverage.

Keywords:

  • Quality Assurance, Quality Control, Regulatory Compliance, SOP, Supplier Audits, MasterControl, Batch Records, Deviations, Change Controls, CAPAs, Out of Specification.