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SPECTRAFORCE · 1 day ago

Senior Quality Assurance Associate

Holly Springs, NC

Contract

Onsite

Senior Level

$30/hr - $33/hr

SPECTRAFORCE is seeking a Senior Quality Assurance Associate to work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction. The role will facilitate real-time decision making to ensure adherence to GMP quality requirements and maintain a strong partnership between Manufacturing and Quality staff.

ConsultingCRMInformation TechnologyLegal

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations

Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls

Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s

Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements

Oversee and provide guidance during on-the-floor analytical testing

Ensure that changes that could potentially impact product quality are assessed according to procedures

Ensure that deviations from established procedures are investigated and documented per procedures

Alert senior management of quality, compliance, supply and safety risks

Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

Identification and implementation of continuous improvement opportunities within our processes and systems

Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections

Qualification

PQA experienceManufacturing backgroundCGMP knowledgeBatch records experienceDeviations oversightContinuous improvementQuality systemsRegulatory interactionCoachingGuidanceProject management

Required

Manufacturing and PQA background