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Quality Assurance (Qa) Manager

NES Global Talent

This is a Full-time position in Atlanta, GA posted March 18, 2021.

QA/ GMP Manager Our client in the Northeast is looking to add a QA Manager to their growing team for the next 6 months.

In this role, you will support our clients teams by providing quality oversight to ensure compliance with cGMP and GCP regulations in support of clinical and commercial activities.

Additionally, you will be responsible for supporting investigational and commercialization GMP/QA activities to ensure compliance (local, state, federal, and global GMP) and will communicate with CMO’s o n the review & release of drug substance, drug product, packaging/labelling batch records and associated documents (e.g.

change controls, deviations, etc).

Required skills: • At least 10 years of Quality Assurance experience in a bio-pharmaceutical environment (experience working in a start-up fast pace culture preferred) • Strong background in with CRO oversight as it relates to clinical supplies and quality assurance • Audit and release clinical manufacturing and validation batch records for completeness and accuracy (Knowledgeable in cGMP (21 CFR Parts 210 & 211) • Review and approve GMP deviations, CAPA’s, investigations and change controls.

• Prior supervisory and training/ mentor experience “‹”‹”‹”‹”‹• Support phase III and commercial validation activities including the review of regulatory submission documents Job Requirements:• Work with CMC, Quality Assurance and Regulatory Affairs to identify, communicate and resolve potential quality issues arising during manufacturing operations.

Monitor trends or signals in potential product quality issues.• Manage all assigned CMO including temperature excursion documentation for our clients files, ensuring electronic and original documents are filed appropriately.• Establish and maintain GMP SOP’s to maintain quality systems with current regulations and industry standards.• Perform audits (CMO and internal) according to the audit plan.• Coordinates and reports the GMP “Management Review” meetings• Supports the Head of QA to host, lead back (War) room during inspection readiness activities and during all regulatory inspections, as assigned.• Additional assignments may include but are not limited to: Assist to review electronic system validation upgradesSDL2017

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