- 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.
- 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.
Prolonged periods of sitting at a desk and working on a computer.
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Quality Pharmacist - Columbus - STAQ Pharma
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:
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Sterile Compounding Pharmacist
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Regional Pharmacist Trainer
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Regional Pharmacist Trainer
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