Quality Assurance Manager
About The Position
Strive Pharmacy is a personalized compounding pharmacy focused on individualized care and partnership with patients and providers. The Quality Assurance (QA) Manager provides site-specific quality oversight, ensuring compliance with Strive Pharmacy’s Standard Operating Procedures (SOPs), specifications, and applicable state and federal regulatory standards. This role leads and manages the QA function at the assigned pharmacy location, overseeing documentation review, label control, investigations, change control, audits, and product release. The QA Manager also supports continuous improvement initiatives and acts as the primary on-site liaison between pharmacy operations, compounding, and corporate Quality leadership.
Requirements
- High School Diploma or GED
- Minimum of five (5) years of experience in a quality or manufacturing role within a pharmaceutical, medical device, or allied health science environment.
- Proven experience in aseptic operations and regulated environments.
- Strong knowledge of QA practices (deviation management, CAPA, change control, and documentation review).
- Proficiency with Microsoft Office Suite and quality management systems (QMS).
- Strong data analysis, trend identification, organizational, and problem-solving skills.
- Ability to stand, sit, or walk for extended periods.
- Ability to occasionally lift up to 45 pounds.
- Ability to work in controlled cleanroom environments.
- Ability to wear required protective attire.
- Ability to tolerate controlled temperatures and background noise.
Nice To Haves
- Associate’s or higher degree in Biology, Microbiology, Chemistry, or Pharmacy.
- Prior experience leading a QA team within a compounding or manufacturing environment.
- Deep familiarity with 503A/503B compounding regulations, USP <795>/<797>/<800>, and FDA 21 CFR 210/211.
- Direct experience participating in or leading regulatory or partner audits.
Responsibilities
- 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.
- Conduct regular audits of compounding, production, cleaning, and validation records to ensure accuracy and compliance with GDP and USP standards.
- Approve equipment calibration and preventive maintenance records.
- 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.
- 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.
- Partner with QA Specialists to investigate non-compliance events and manage third-party testing.
- Lead external regulatory, partner, or client audits in collaboration with the Pharmacist-in-Charge (PIC).
- Conduct regular internal compliance audits.
- Track and report weekly site quality metrics and trend data directly to the Director of Quality.
- Approve or reject compounded products, raw materials, and components based on testing results.
- Pause or halt pharmacy operations when immediate quality, safety, or compliance risks are identified.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
