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Quality Assurance Specialist

  • Full Time, onsite
  • Infotree Global Solutions
  • Frederick, United States of America
Salary undisclosed

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Responsibilities:

• Provide QA support on the floor for production

• Ensure process control measures are in place and followed in product manufacturing

• Receipt and disposition of incoming apheresis material.

• Oversee and authorize the shipment of final product

• Ensure all product-related Deviations are initiated, investigated and resolved.

• Ensure that associated CAPAs are initiated and resolved, as needed.

• Perform lot closure activities.

• Ensure approval and timely delivery of final product.

• Ensure products are manufactured in compliance with regulatory and GMP guidelines.

• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

Basic Qualifications:

• BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR

• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

• High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

Preferred Qualifications:

• BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

• 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.

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description