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Quality Assurance Engineering Specialist

1 month ago

Philadelphia, United States Meet Full time

Join our exciting growing Biotech client - they are hiring a QA Engineering Specialist/Senior level to join their team


Position Title: Quality Assurance Engineering Specialist

Department: Quality Assurance

Location: Onsite Manufacturing Site, Philadelphia, PA

Reports To: Quality Assurance Manager

Job Summary:

As a Quality Assurance Engineering Specialist in the pharmaceutical industry, you will play a critical role in ensuring the quality and compliance of our products throughout the development and manufacturing processes. You will collaborate with cross-functional teams to implement quality assurance strategies, conduct risk assessments, and ensure adherence to industry regulations and standards.


Key Responsibilities:

  • Quality Oversight: Monitor and evaluate manufacturing processes, ensuring compliance with Good Manufacturing Practices (GMP), FDA regulations, and other applicable guidelines.
  • Documentation Review: Review and approve quality documentation, including batch records, standard operating procedures (SOPs), and validation protocols.
  • Risk Management: Conduct risk assessments and implement quality control measures to mitigate potential issues in product quality.


Qualifications:

Education: Bachelor’s degree in Pharmacy, Chemistry, Engineering, or a related field. Advanced degrees or certifications (e.g., CQE, CQA) are a plus.

Experience: Minimum 2-3 years of experience in quality assurance or quality control within the pharmaceutical or biotech industry.


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