Quality Pharmacist - Columbus - STAQ Pharma

    STAQ Pharma
    STAQ Pharma Columbus

    1 day ago

    Description
    Job Summary:
    The Quality Pharmacist supports quality operations in a 503B outsourcing facility, ensuring all compounded sterile preparations meet regulatory and company quality standards. This entry-level role provides exposure to quality assurance, regulatory compliance, and compounding oversight under cGMP and FDA guidelines. The position assists with documentation review, investigations, and audits while promoting a culture of safety and continuous improvement within pharmaceutical operations
    Responsibilities:
    • Review batch records and documentation for accuracy, completeness, and compliance with SOPs and cGMP.
    • Support environmental monitoring, media fills, and sterility assurance activities.
    • Participate in deviation investigations, corrective and preventive actions (CAPA), and change control processes.
    • Assist in internal and external audit preparation and responses.
    • Verify labeling, packaging, and final product release documentation.
    • Complete annual product reviews.
    • Submit biannual reporting to FDA for compounded products.
    • Obtain and maintain pharmacist licensure in multiple states.
    • Support maintenance of compliance with FDA, DEA, USP
      • Strong understanding of pharmaceutical compounding and cGMP fundamentals.
      • Excellent organizational, analytical, and problem-solving skills.
      • Strong written and verbal communication abilities.
      • Proficiency with Microsoft Office and familiarity with electronic quality management systems (QMS).
      • High attention to detail and ability to manage multiple priorities.
      • Willingness to learn regulatory compliance principles for 503B operations.
      • Excellent time management skills with a proven ability to meet deadlines.
      • Strong analytical and problem-solving skills.
      • Strong supervisory and leadership skills.
      • Ability to prioritize tasks and to delegate them when appropriate.
      • Ability to function well in a high-paced and at times stressful environment.
      • Proficient with Microsoft Office Suite or related software.
      Education and Experience:
      • Doctor of Pharmacy (PharmD) degree required.
      • 0+ years of experience in a compounding pharmacy or cGMP-regulated pharmaceutical setting (internship or rotation experience acceptable).
      • Knowledge of USP
        • Pharmacist will apply for licensure in any state(s) that STAQ requests them to do so, at STAQ's cost and expense.
        • Pharmacist will allow STAQ to use their license for any site in which STAQ is licensed or applying to be licensed.
        Physical Requirements:
        Prolonged periods of sitting at a desk and working on a computer.

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