Regulatory Compliance Technician
Karen K McKinnon
CompleteRx
GREENVILLE,TX
Work Preference
Work Type
Full Time
Location Preference
Remote
Minimum Desired Compensation
$72000/yr
Important To Me
Work-life balanceHealthcare benefitsWork from home optionPaid time offPaid sick leave401k matchCareer advancementCompany Culture
1
Certification
18
years of professional experience
Detail-oriented professional with deep experience in pharmacy compliance, sterile compounding, and regulatory audits. Known for accurate reporting, thorough risk assessments, and clear documentation. Consistently partnered with cross-functional teams to improve procedures and support strong compliance outcomes.
Work History
Regulatory Compliance Analyst
3 Years 5 Months- Monitored regulatory changes and updated internal documentation to maintain policy accuracy.
- Analyzed compliance data to detect trends, exceptions, and recurring process risks.
- Reviewed pharmacy compliance processes to identify gaps and align procedures with federal and state regulations.
- Supported audit preparation by gathering records, validating files, and organizing required documentation.
- Coordinated corrective action follow-up to resolve findings and improve control adherence.
- Maintained accurate records for investigations, training, and regulatory reporting requirements.
- Improved regulatory compliance levels by conducting thorough risk assessments and developing effective control measures.
- Tracked policy implementation issues and recommended process improvements to strengthen regulatory adherence.
- Partnered with cross-functional teams to clarify compliance expectations and support procedure updates.
- Assisted with development of compliance objectives and strategies.
- Developed and implemented corrective action plans for non-compliance issues.
- Conducted periodic compliance audits and reviews to identify areas of improvement.
Senior Pharmacy Technician
4 Years- Prepared medications and sterile products under pharmacist supervision, following hospital safety and accuracy standards.
- Managed medication inventory, restocking, and expiration checks to support uninterrupted pharmacy operations.
- Coordinated with nurses and pharmacists to resolve dispensing issues and prioritize urgent medication needs.
- Maintained compliance with USP, controlled substance, and facility documentation requirements.
- Trained new pharmacy technicians on workflow procedures, medication handling, and system navigation.
- Reduced medication errors by meticulously verifying prescription information and conducting thorough drug interaction checks.
- Improved patient safety by ensuring accurate medication dispensing and proper dosage calculations.
- Maintained a clean and organized pharmacy environment, ensuring compliance with state regulations and safety standards.
- Demonstrated expertise in compounding medications, delivering high-quality custom formulations for patients'' unique needs.
- Stocked, labeled, and inventoried medication to keep accurate records.
Senior Pharmacy Technician
12 Years 9 Months- Audited pharmacy records and replenishment processes to support quality control and regulatory readiness.
- Supervised sterile compounding workflow to maintain accuracy and compliance with USP standards.
- Prepared IV admixtures using aseptic technique for timely patient-specific medication delivery.
- Verified ingredient selection and labeling to reduce compounding errors and support pharmacist review.
- Compounded sterile IV preparations using aseptic technique and USP compliance standards.
- Verified medication orders for accuracy before preparing IV admixtures.
- Maintained cleanroom sanitation, garbing, and hood workflow to support contamination control.
- Prepared TPN, antibiotics, and other IV solutions according to pharmacy protocols.
- Tracked IV inventory, expiring products, and supply levels to prevent shortages.
- Documented compounding activities in pharmacy systems with precise recordkeeping.
- Coordinated with pharmacists and nursing teams to resolve medication preparation issues.
- Streamlined pharmacy operations by implementing efficient medication storage and retrieval systems.
- Reduced medication errors by diligently verifying prescription information and dosage calculations.
- Demonstrated expertise in specialty areas such as oncology or pediatrics through targeted training programs leading to enhanced patient care.
- Contributed to regulatory compliance by maintaining accurate records for controlled substances and conducting periodic audits.
- Maintained a safe work environment by adhering to strict sterile compounding procedures and following infection control protocols.
- Managed opening and closing duties for pharmacy.
- Ordered medicines daily to replenish stock and increase inventory in anticipation of need.
- Monitored ordering of pharmacy medication stock to maintain streamlined inventory and low overhead.
- Developed and implemented improvements to pharmacy organization system.
- Stocked, labeled, and inventoried medication to keep accurate records.
Education
Bachelor of Science - Data Analysis
- Honoree of Honor Society - May 2022
- Professional Development: Data Analysis, Statistics, Organizational Management, Conflict Resolution, Technical Communications
Skills
Compliance oversight
Regulatory reporting
Regulatory audit
Document review
Detail orientation
Problem-solving
Multitasking
Team collaboration
Time management
Reliability
Certification
- CPhT - Certified Pharmacy Technician
- IV and Sterile Compounding License
- IV Chemotherapy and Hazardous Drug Compounding
Timeline
Regulatory Compliance Analyst
CompleteRx
05.2023 - CurrentRead More
Senior Pharmacy Technician
CompleteRx
10.2022 - CurrentRead More
Senior Pharmacy Technician
Texas Oncology
01.2009 - 10.2021Read More
University of North Texas
Bachelor of Science from Data Analysis
Read More