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Quality Specialist 4 – Vaccine

Ampcus Inc.

This is a Full-time position in Atlanta, GA posted June 21, 2021.

Description:

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

Job Requirements:

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


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