Quality Assurance Lead (CAPA Specialist)
Job Description
Job Description
Job Summary:
The Quality Assurance Lead is responsible for ensuring the quality and compliance of all materials used in compounding operations. This role requires management and oversight of documentation, training, and regulatory readiness to support safe and efficient 503A non-sterile and hazardous compounding practices. The coordinator ensures continuous compliance with USP 795, 800, FDA, DEA, OSHA, HIPAA, and state board regulations across all TPH compounding facilities.
Key Responsibilities:
Compounding / Quality & Compliance
• Own and maintain all compounding documentation (equipment logs, cleaning records, destruction
• records).
• Design, deliver, and document initial ongoing training for compounding staff; verify competency.
• Supervise laboratory QC activities; review and trend analytical data.
• Investigate and document temperature excursions outside the lab and implement CAPA.
General Administrative Duties
• Direct the Pharmacy Technician Program from onboarding through completion, ensuring alignment
• with state requirements.
• Coordinate locker/asset assignments for new hires in partnership with HR.
• Conduct cross-department USP/job-role assessments and issue corrective coaching.
• Monitor OSHA/USP/FDA/DEA updates; communicate changes and integrate into practice.
• Track facility maintenance, schedule PMs, and issue monthly compliance reports.
Compliance & Licensing
• Write, revise, and implement SOPs, policies procedures (P&P) for both TPH sites; manage version control and staff acknowledgement.
• Lead inspection-readiness activities, including mock audits, document rooms and staff preparedness.
• Serve as HIPAA Privacy Security Officer for the compounding division; oversee daily compliance,
• breach investigations and staff training.
Qualifications:
• Fluent in English; bilingual proficiency in Spanish preferred.
• Florida Registered Pharmacy Technician License
• Flexible work schedule, including weekends.
• 2-3 years in non-sterile/sterile compounding quality, QA/QC, or compliance.
• Proven ability to multitask effectively.
• Strong attention to detail and organizational skills.
• Knowledge of nonsterile/sterile compounding best practices
• Proficient in Microsoft
• Excellent documentation and recordkeeping skills.
• Familiarity with pharmacy software systems.
• Experience in a compounding pharmacy or healthcare environment.
Job Type: Full-time - 100% On Site
Expected Hours: 40 hours per week - Ability to Work overtime required
Work Schedule:
Monday – Friday, 9 AM – 5:30 PM
Pay Range
$22 - $28 USD
Benefits:
- 401(k) with up to 4% matching
- Medical, dental, vision and life insurance
- Paid time off
- Paid public holidays
Company DescriptionPrideStaff Financial is a national staffing organization, delivering innovative solutions to the challenges employers face every day. Over the years, PrideStaff Financial has been a consistent industry leader, developing technology and service processes that allow our organization to deliver superior performance. With locations across the United States, we're well positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs. When it comes to your success, we leave nothing to chance!
Our Mission: Consistently provide client experiences focused on what they value most.
Company Description
PrideStaff Financial is a national staffing organization, delivering innovative solutions to the challenges employers face every day. Over the years, PrideStaff Financial has been a consistent industry leader, developing technology and service processes that allow our organization to deliver superior performance. With locations across the United States, we're well positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs. When it comes to your success, we leave nothing to chance! \r\n\r\nOur Mission: Consistently provide client experiences focused on what they value most.