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Position Overview:
We’re seeking an experienced professional to support aseptic preparation and related production functions in a regulated pharmaceutical environment. This individual will be involved in sterile formulation, quality assurance activities, and general laboratory support outside of the cleanroom.
Core Responsibilities:
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Support compounding operations under the supervision of licensed pharmacy leadership.
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Execute aseptic processing techniques in alignment with industry standards and internal quality protocols.
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Conduct quality control checks and assist with documentation and sample submission to third-party labs.
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Participate in environmental monitoring procedures, including surface and air sampling.
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Monitor material usage and assist in inventory management to maintain adequate supply levels.
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Assist with the upkeep, troubleshooting, and validation of lab equipment used in cleanroom operations.
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Review and revise operational procedures (SOPs) when assigned.
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Participate in internal investigations related to product discrepancies or failures.
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Support cross-functional projects, including non-laboratory tasks as needed.
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Contribute to scientific initiatives that align with organizational goals under appropriate guidance.
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Promote a safe working environment and adhere to all health and safety standards.
Preferred Background & Credentials:
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Minimum of five years of compounding or formulation experience, including at least one year in sterile environments.
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Active pharmacy technician certification in the state of Florida is required.
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Familiarity with aseptic processing standards, including USP <795> and USP <797>.
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Experience with FDA cGMP regulations relevant to outsourcing facilities (503B) is a plus.
Desired Attributes:
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High attention to detail with a strong focus on quality and regulatory adherence.
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Capable of managing documentation, organizing work efficiently, and communicating clearly across teams.
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Proficient in using digital tools for reporting and data entry (Microsoft Word and Excel).
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