Location: Tampa, Florida
Position Type: Full Time
Schedule: 1st Shift; 8am - 4pm
Compensation Range: $80,000 - $90,000
Position Summary:The
Quality Assurance (QA) Manager provides site-specific quality oversight and ensures full compliance with Strive Pharmacy's Standard Operating Procedures (SOPs), specifications, and applicable state and federal regulatory standards. Reporting to the National Quality Assurance Manager, this position leads and manages the QA function at the assigned pharmacy location. Responsibilities include documentation review, label control, investigations, change control, audits, and product release. Additionally, the QA Manager supports continuous improvement initiatives and serves as the primary on-site liaison between pharmacy operations, compounding, and corporate Quality leadership.
Key Responsibilities:- Team Leadership & Development: Supervise the site QA team by managing workloads, timecards, performance reviews, and discipline. Lead candidate interviews, oversee onboarding and competency training, and conduct routine team meetings and cross-department huddles.
- Documentation & Compliance Review: Conduct regular audits of compounding, production, cleaning, and validation records (including media fills and BMS/temperature alarms) to ensure absolute accuracy and compliance with GDP and USP /// standards. Approve equipment calibration and preventive maintenance records.
- Material & Label Control: Verify and reconcile all physical and electronic labeling to maintain strict accountability. Review supplier qualification records to ensure materials are sourced exclusively from approved, compliant vendors.
- Quality Systems & Event Management: Triage customer complaints and coordinate with corporate QA to report adverse drug events. Review and approve deviations, non-conformances, Corrective and Preventive Action (CAPA), and change controls, partnering with QA Specialists to investigate non-compliance events and manage third-party testing.
- Auditing & Metrics Reporting: Lead external regulatory, partner, or client audits in collaboration with the Pharmacist-in-Charge (PIC), and conduct regular internal compliance audits. Track and report weekly site quality metrics and trend data directly to the Director of Quality.
- Site Authority: Authorized to approve or reject compounded products, raw materials, and components based on testing results. Fully authorized to pause or halt pharmacy operations when immediate quality, safety, or compliance risks are identified.
Required Qualifications:- Education & Experience: High School Diploma or GED with a minimum of five (5) years of experience in a quality or manufacturing role within a pharmaceutical, medical device, or allied health science environment.
- Technical Expertise: Proven experience in aseptic operations and regulated environments , alongside strong knowledge of QA practices (deviation management, CAPA, change control, and documentation review)
- Core Skills: Proficiency with Microsoft Office Suite and quality management systems (QMS) , paired with strong data analysis, trend identification, organizational, and problem-solving skills.
- Physical & Environmental: Ability to stand, sit, or walk for extended periods, and occasionally lift up to 45 pounds. Must be able to work in controlled cleanroom environments, wear required protective attire, and tolerate controlled temperatures and background noise.
Preferred Qualifications:- Advanced Education: Associate's or higher degree in Biology, Microbiology, Chemistry, or Pharmacy.
- Industry Leadership: Prior experience leading a QA team within a compounding or manufacturing environment.
- Regulatory Knowledge: Deep familiarity with 503A/503B compounding regulations, USP //, and FDA 21 CFR 210/211.
- Audit Experience: Direct experience participating in or leading regulatory or partner audits.
Work Environment: This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities.
Core Competencies- Accountability: Takes ownership of site quality performance and compliance outcomes.
- Attention to Detail: Maintains exceptional accuracy in documentation and review activities.
- Leadership: Guides and develops QA personnel to uphold Strive's culture of quality and excellence.
- Decision-Making: Exercises sound judgment in product release and quality escalation.
- Communication: Effectively collaborates across teams and with corporate leadership.
- Continuous Improvement: Proactively identifies opportunities to enhance quality systems and reduce risk.
Annual Salary
$80,000-$90,000 USD
Benefits/ Perks: Strive Pharmacy offers a comprehensive benefits package, including:
- Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
- Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
- Paid time off
- Sick time
- FSA and HSA options
- Parental leave
- 401(k) with employer matching
- Life insurance
- Vision and dental insurance
- Veterinary insurance
