Quality Pharmacist

Nephron Pharmaceuticals Corporation • Full-time • West Columbia, SC, US • 11h ago

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Description

Essential Duties and Responsibilities:

Collaborate cross-functionally with Manufacturing, Engineering, MS&T, and Quality teams to support continuous improvement initiatives
Conduct holistic reviews of manufacturing and packaging batch records for accuracy, completeness, aseptic processing guidelines, and compliance with GMP and procedures.
Evaluate environmental monitoring data, personnel monitoring data, sterilization processes, and batch related specifications as part of the holistic review process.
Identify discrepancies, documentation errors, or atypical events, and collaborate with cross-functional teams (Production, QC, Validation, Engineering) to ensure timely resolution through deviation investigations and CAPAs.
Apply a holistic quality approach by integrating batch record review with data from deviations, complaints, OOS, OOT, change controls, media fill performance, and audit findings.
Review batch record checklist to verify all requirements have been performed and meet requirements.
Collaborate with Production, QA, QC, Regulatory Affairs, and other departments to resolve issues and ensure batch readiness for release.
Execute and support CAPA-related projects, including root cause analysis, implementation of corrective and preventive actions, and effectiveness checks
Support product and process development studies, including protocol development, execution support, data review, and documentation to ensure alignment with quality and regulatory requirements
Support implementation of the organization's quality risk management program through participation in risk-related activities (e.g. risk assessment, risk reduction) and development / maintenance of risk management documentation
Support deviations, investigations, and change controls through data gathering, documentation, and implementation of actions
Maintain up-to-date knowledge of applicable regulatory standards (FDA, EMA, ICH) and ensure compliance across documentation.
Ensure all work is documented in accordance with cGMP requirements, maintaining accuracy, completeness, and data integrity
Contribute to inspection readiness efforts, including documentation support and response to audit observations
Identify and support process and operational improvements across development and manufacturing activities

Requirements

Education / Experience:

PharmD or Bachelor of Pharmacy is required
Active registered pharmacist licensure in South Carolina is required within six months of hire date
1-3 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP preferred

Working Conditions / Physical Requirements

Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.
Ability to work in cleanroom environments, including gowning requirements.

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