Quality Pharmacist

Nephron Pharmaceuticals

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.

o 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.

Equal employment opportunity, including veterans and individuals with disabilities.

PI285332816