Quality Assurance Specialist

4 days ago

Frederick, Maryland, United States Unicon Pharma Inc Full time
Job Title: Quality Assurance Specialist

About the Role:

Unicon Pharma Inc is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities:

  • Provide quality assurance support on the production floor to ensure compliance with regulatory requirements and company policies.
  • Develop and implement process control measures to ensure the quality of our products.
  • Oversee the receipt and disposition of incoming materials, including apheresis material.
  • Authorize the shipment of final products and verify the timely issuance of production documents and labels.
  • Review batch-related documentation and ensure the resolution of issues to release and ship products.
  • Gather and report metrics to measure performance and identify areas for improvement.
  • Identify and implement continuous improvement actions to enhance the quality of our products.
  • Ensure timely resolution and escalation of issues, including deviations and CAPAs.
  • Perform lot closure activities and ensure the approval and timely delivery of final products.
  • Ensure that our products are manufactured in compliance with regulatory and GMP guidelines.
  • Provide quality assurance support in resolving material, in-process product, final product, environmental, facility, and equipment manufacturing issues.

Requirements:

  • Bachelor's degree in a technical discipline, such as chemistry, microbiology, or engineering, and experience in quality assurance or a GMP environment.
  • Associate's degree in a technical discipline and 2+ years of quality assurance experience in a GMP environment.
  • High school diploma and 5+ years of quality assurance experience in a GMP environment.

Preferred Qualifications:

  • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards.
  • Ability to effectively negotiate and build collaboration amongst individuals.
  • Strong teamwork and collaborative skills.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • General knowledge of aseptic manufacturing processes.
  • Proficient in MS Word, Excel, PowerPoint, and other applications.
  • Strong interpersonal, verbal, and written communication skills.
  • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
  • Willingness to think outside of the box and adapt best practices to a small, but growing environment.
  • Must be able to work on multiple assignments in a collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

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