Quality Assurance Specialist

15 hours ago


Frederick, United States ACL Digital Full time

Title: Quality Assurance Specialist

Location: Frederick, MD

Duration: 12 months


Shift - SUN - WED 7am-5:30pm


***Shift is Sun-Wed 7am- 5:30 pm***

*** This position will be 100% On-Site***


Responsibilities (included but not limited to):

• 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 shipment of final product

• Verify and ensure timely issuance of production documents and labels

• Review batch-related documentation and ensure resolution of issues to release and ship product.

• Gather and report metrics to measure performance

• Identify continuous improvement actions

• Ensure timely resolution and escalation of issues

• 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.

• Perform other duties as assigned


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.

• Proficient in MS Word, Excel, Power Point and other applications.



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