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Quality Specialist 4 - Vaccine job in Atlanta at Ampcus Inc.

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Quality Specialist 4 - Vaccine at Ampcus Inc.

Quality Specialist 4 - Vaccine

Ampcus Inc. Work From Home Full Time
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Specialist IV – Quality

NCL/OMCL Process Support

Must be local to Northern America region but will be 100% virtual

Key Responsibilities:

Maintain high-level oversight of all Drug Substance (DS) and Drug Product (DP) lots manufactured throughout the production network

Liaise with samples coordinators at external manufacturers to schedule and execute samples shipments to NCL/OMCLs (National Control Laboratories/Official Medicines Control Laboratories)

Schedule shipping route verification studies and review/approve shipping route verification reports to validate shipping lanes across the network in timely manner

Should samples arrive with alarmed temperature monitor, advise on product disposition

Ensure samples are tracked in eLIMS accurately and in a timely manner

Lead process improvement initiatives to streamline samples sending/receipt processes

Manage process for sending/receiving backup samples as needed

Provide support documentation preparation and submission to health agencies as needed

Complete and pass all applicable training required for access to quality and information management systems (i.e. ETS Trackwise, eLIMS etc.)

Complete and pass all applicable Good Manufacturing Practice training and general quality management training

Learning and remaining current with local regulations, guidelines and quality practices associated with the vaccines industry is required

Experience / Knowledge Required:

         Bachelor’s Degree in engineering, science, or an equivalent technical discipline

         Minimum of 4 years working in an FDA-regulated environment, preferably in a pharmaceutical or biologics manufacturing environment

         Basic understanding of aseptic processing principles

         Proficiency in computer applications such as Microsoft Office Suite

         Must have strong ability to maintain high efficiencies and accuracy in data entry

         Detail-oriented, with ability to quickly process complex information and make critical decisions with limited information at times

         Strong interpersonal, written, and oral communication skills

Experience / Knowledge Preferred:

         Experience in the NCL/OMCL process for vaccine government approval/release

         Previous experience in work environment under cGMP regulation highly desirable

         Experience in Vaccine Production/QA

         Proficient in applying process excellence tools and methodologies

         Experience working with external manufacturers or laboratories

Advanced degrees are a plus and may reduce the experience required

Recommended Skills

Aseptic Processing
Batch Release
Quality Assurance

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