The Fountain Group
The QA Specialist demonstrates sufficient depth of knowledge within own work area in order to perform hands‑on routine QA tasks. This role supports Operations including batch record, investigation, and document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing with guidance/coaching. Project work, as needed, will also be expected.
Duties
Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required.
Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with standard processes and quality systems.
Conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs).
Conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing.
Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations.
Escalate issues as appropriate to the Quality Assurance Management in a timely manner.
Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Quality Assurance approval of SOPs, Campaigns start up Form and QA validation protocols and reports.
Maintain inspection readiness and support internal/external audits as needed.
Interface with Regulatory Agencies in audits.
Qualifications
Bachelor's degree with 1+ years of experience in GMP Pharmaceutical manufacturing environment required. Knowledge of pharma QMS/Quality Systems desired.
Hands‑on Quality Assurance experience in a cGMP manufacturing environment including batch record and logbook review, deviation support, documentation control, and QA oversight on the manufacturing floor.
Strong knowledge of regulatory compliance and quality systems (GMP, SOPs, deviation investigations, audit readiness) — ability to ensure product quality, conduct walkthroughs, and interface with regulatory bodies during inspections.
Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
Ability to work in a fast‑paced environment and be able and willing to juggle priorities as required.
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Duties
Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required.
Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with standard processes and quality systems.
Conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs).
Conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing.
Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations.
Escalate issues as appropriate to the Quality Assurance Management in a timely manner.
Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Quality Assurance approval of SOPs, Campaigns start up Form and QA validation protocols and reports.
Maintain inspection readiness and support internal/external audits as needed.
Interface with Regulatory Agencies in audits.
Qualifications
Bachelor's degree with 1+ years of experience in GMP Pharmaceutical manufacturing environment required. Knowledge of pharma QMS/Quality Systems desired.
Hands‑on Quality Assurance experience in a cGMP manufacturing environment including batch record and logbook review, deviation support, documentation control, and QA oversight on the manufacturing floor.
Strong knowledge of regulatory compliance and quality systems (GMP, SOPs, deviation investigations, audit readiness) — ability to ensure product quality, conduct walkthroughs, and interface with regulatory bodies during inspections.
Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
Ability to work in a fast‑paced environment and be able and willing to juggle priorities as required.
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