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Aequor · 1 week ago

Quality Assurance Senior Associate

Holly Springs, NC

Full-time

Onsite

Senior Level

Aequor is a company focused on quality assurance within the pharmaceutical manufacturing industry. They are seeking a Senior Associate Plant Quality Assurance (PQA) to work directly with plant manufacturing and support groups, ensuring adherence to GMP quality requirements and facilitating real-time decision making.

ConsultingIT ManagementRecruiting

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 *** 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

Manufacturing backgroundPQA backgroundCGMP complianceQuality oversightContinuous improvementProject managementAnalytical testingCoachingGuidanceRegulatory interaction

Required

Manufacturing and PQA background

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