Pharmacy Audit Technician
About The Position
The Pharmacy Audit Technician will be responsible for supporting Quality Assurance (QA) activities in compliance with FDA/DEA/State Regulations, cGMP, and company policies, procedures and specifications at the company distribution center. Perform the day to day QA activities in a distribution center environment with responsibility for the quality of drug products and dietary supplements. This will include the review and approval of documentation (batch manufacturing records and/or packaging records, deviations, complaints investigations, etc.), change control, and continuous QA improvement. The QA Associate position will need a robust understanding of the applicable regulations, standards, and guidance(s) to ensure regulatory compliance. The Pharmacy Audit Technician is expected to perform the above activities in partnership with other departments at the distribution center. This position will interact with both internal and external customers to include members of senior management.
Requirements
- High School diploma or equivalent
- Experience in a pharmacy setting and with medical terminology
- Ability to operate a computer
- ability to recognize and identify medications
- Detail oriented
- goal oriented
- team player
- effective oral communication
Nice To Haves
- Licensed Pharmacy Technician, preferred but not required
- Previous experience working in a pharmacy, Long-Term Care pharmacy,preferred
- Long Term Care pharmacy experience preferred
Responsibilities
- Performs documentation reviews with a high attention to detail using working knowledge of quality concepts and internal procedures
- Initiates, writes, drives deviations and CAPAs to ensure that all quality issues are thoroughly addressed and documented
- Participates in Change Control activities
- Receives and logs product quality complaints
- Performs all QA activities that lead to closure
- Writes, reviews, and approves standard operating procedure (SOPs) and other applicable operation related GMP documents
- Compiles Annual Product Reviews (APRs)
- Performs Periodic reviews of SOPs
- Supports and participates in trending of Quality metrics
- Assists in the GMP auditing program for internal and external (FDA, DEA, and State) audits
- Supports the development, continuous improvement, and maintenance of the Quality System
- Guides, develops, and trains other functional areas in areas of QA subject matter
- Accomplishes goals by completing related activities as assigned thoroughly and in a timely manner.
- Maintains a safe and healthy work environment by following written standards and complying with regulatory requirements
Benefits
- Health, dental, and vision insurance
- Life insurance
- Paid Time Off
- 6 Company Holidays
- DailyPay
- Company-Paid Disability Insurance – Both short-term and long-term.
- 401k Plan
- Tuition Reimbursement
- Employee Discount Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
