Quality & Inventory Specialist
2 months ago
Role and Responsibilities
This position reports to the Pharmacist in Charge and the Chief Quality and Strategy Officer. The Quality & Inventory Specialist is responsible for many areas, including but not limited to the following:
- Incoming materials receipt: Review C of A documents for quality control and vendor compliance
- Sample submission to third party labs: potency testing of finished goods. Enter results into document management system
- Proficient in PK software: Compounding record and log review
- Perform in process inspection and quality checks of compounded preparations
- Assist PIC with investigating complaints related to the quality of compounded prescriptions
- Initiate and follow through on quality related tasks including deviations, investigations, and CAPA
- Assist Compounding Pharmacist Manager with non-sterile compounding technician training program
- Conducts routine quality self-audits on the facility to assure compliance with company and regulatory standards are being met
- Participate in all pharmacy inspections, including but not limited to: Board of Pharmacy, NABP, FDA, and DEA
- Collaborate with Corporate Quality department in writing and implementing Standard Operating Procedures (SOPs)
- Attends and actively participates in all quality and procurement department meetings
- Attends company procurement and inventory meetings
- Sets an example by always following assigned SOPs
- Knowledgeable in Acumatica Software and use for procurement and inventory management
- Procurement and inventory of key pharmacy stock, includes routine cycle counts and month end inventory
**KEY SKILLS**:
- Understanding of Wisconsin Board of Pharmacy compounding regulations, FDA 503A regulations, and USP 795, 800 standards
- Exceptional attention to detail
- Good Documentation Practices (cGDP) experience preferred
- Compounding lab experience & experience wearing Personal Protective Equipment (PPE) preferred
- Excellent verbal and written communication skills
- Experience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programs
- Strong work ethic and ability to work effectively as a team in a fast-paced environment
- This is a 100% on-site position. Reliable transportation and punctuality are required.
Education Requirements:
- Wisconsin technician registration required
- Bachelor of Science or related degree preferred.
Additional Notes
- Must be able to lift items repeatedly (lifting as a team for heavier items)
- Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
- Must be able to wear required PPE for extended periods of time
- Position requires handling of cleaning chemicals or hazardous materials
- Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned
- This is a 100% on-site position. Reliable transportation and punctuality are required.
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