Senior Sterile Compounding Pharmacist

Austin Community College; Florida; Sur place; USD 80 000 - 100 000; Plein temps

Résumé du poste

A community college in New York is seeking a dedicated Pharmacist to ensure safety and compliance in sterile drug compounding. The ideal candidate will hold a Pharm.D. and have at least one year of compounding experience. Responsibilities include supervising QA processes, maintaining compliance with FDA regulations, and managing inventory. This full-time role requires strong aseptic techniques and collaboration skills within a multidisciplinary team environment, with hours from 6 am to 6 pm.

Qualifications

• Active pharmacist license in Florida is required.
• At least 1 year of experience in pharmacy compounding.
• Knowledge of FDA and DEA regulations.

Responsabilités

• Utilize knowledge of USP797/800 regulations.
• Supervise production and QA activities.
• Maintain compliance with FDA and cGMP guidelines.

Connaissances

Aseptic technique

Compounding sterile drug products

Compliance with FDA regulations

Quality Assurance

Collaboration in team settings

Formation

Doctor of Pharmacy (Pharm.D.)

Description du poste

You are viewing a preview of this job. Log in or register to view more details about this job.

We are seeking a dedicated and knowledgeable Pharmacist to join our team. The ideal candidate will possess a strong background in pharmacy compounding and sterile drug products. This role is essential for ensuring safety and compliance in the development and creation of compounded sterile drug medications.

Responsibilities:

• Utilize and implement strong knowledge of USP797/800 sterile compounding and hazardous drugs regulations.
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws.
• Responsible for proper communication with QA.
• Supervise various production and quality control activities including end-product chemical testing, end-product sterility testing, and media fills.
• Ability to supervise technicians and other staff members and establish priorities of workflow.
• Monitoring/maintaining drug inventories and preparing orders for drugs and related supplies.
• Organize assigned workload to facilitate its accomplishments.
• Ability to make Quality decisions related to maintenance of aseptic conditions within the clean rooms with a focus on Sterility Assurance during manufacturing operations.
• Manages others to ensure appropriate SOPs ad training documents are in place and effective.
• Manages others to maintain site documents supporting the commercial manufacturing and release of sterile injectable products.
• Upholds operational standards including performance metrics, safety and compliance.
• Responsible for the development and evaluation of proposed formulations, processing, compounding, filtration procedures, and selection of container/closure systems.
• Manufacture of stability batches, stability testing coordination with external laboratories and review data.
• Prepare Master Batch Records, Packaging Records, and Stability Protocols; and coordinate execution with pharmacy staff.
• Write, review and revise SOPs.
• Supports Medical Affairs Department.

Qualifications:

• Doctor of Pharmacy (Pharm.D.) degree from an accredited institution or equivalent education and experience.
• Active pharmacist license in the state of Florida.
• Knowledge and familiarity of working with FDA, DEA and State Pharmacy Boards.
• Thorough understanding and competency with aseptic technique and safe handling of hazardous drugs.
• At least 1 year of experience in pharmacy compounding of sterile drug products.
• Ability to create detailed written procedures and verbal instructions with staff.
• Quality and cGMP conscious and 503B FDA Guidance Practices.
• Ability to work collaboratively within a multidisciplinary team environment.

Hours:

The hours of operation are between 6 am to 6 pm, 40 hours weekly. May require occasional overtime and weekends as needed.