Quality Assurance Manager

1 month ago


Fort Lauderdale, United States Hallandale Pharmacy Full time

Job Summary:


Hallandale Pharmacy is a dynamic and fast-paced 503A compounding pharmacy. We take pride in offering a broad list of quality healthcare products to our clients. The Quality Assurance Manager oversees the QA compounding team, responsibilities include hiring and training staff, knowledge of industry regulatory standards, full understanding of the pharmacy inspections process, this position requires a top performer who is an effective communicator and extremely organized. This position reports to the Director of Quality.


Duties and Responsibilities:

  • Oversees the QA and sterile boxing teams.
  • Ensures compliance with state and federal regulations and accreditation agencies governing the pharmacy practice.
  • Serves as subject matter expert for on-site inspections and assists with required documentation.
  • Makes recommendations for the QA process, system, and department improvements.
  • Maintains regulatory documents and ensures assessments and required documents and trainings are updated.
  • Organizes and maintains master formulation and compounding records, maintains files.
  • Performs stability studies on new medication products.
  • Keeps records of customer complaints, reactions and feedback on all medication products.
  • Operates the site monitoring system and ensures that the temperature is adequate for each site.
  • Collaborates with other departments to resolve questions and customer service-related matters.
  • Acts as the subject matter expert for the department to assist with questions and training for staff.
  • Ensures regulatory assessments for staff is being completed in a timely manner.
  • Assists in coordinating and tracking OSHA trainings for staff.
  • Creates and maintains all departmental SOPs.
  • Ensures staff follows all laboratory SOPs and all other safety policies and procedures.
  • Ensures staff follows all SOPs with regard to proper use of personal protective equipment before entering the lab at all times.
  • Documents and manages the inventory for all controlled substances as per regulatory standards.
  • Properly uses, calibrates, and maintains compounding equipment.
  • Certifies that all compounding machinery is cleaned and sanitized as per regulatory standards.
  • Maintains housekeeping standards in the compounding areas.
  • Performs other related duties as assigned by management or direct supervisor.



SUPERVISORY RESPONSIBILITIES:

Hires, trains, and disciplines staff on quality assurance and compounding procedures, safety protocols, and regulatory requirements.

Manages the performance of the staff.

Develops and implements ongoing safety and standard operating training programs for staff.



Skills & Abilities:

  • Excellent organizational and time management skills.
  • Excellent attention to detail.
  • Excellent verbal and written communication skills.
  • Excellent management and training skills.
  • Ability to multitask/work in a standing environment.
  • Proficiency with pharmacy software and computer systems.
  • Ability to work well in a team environment.



Education & EXPERIENCE :

  • Bachelor’s degree in biology, chemistry, science or related field.
  • Registered or Certified Pharmacy Technician (CPhT) certification is required.
  • Active FL Pharmacist license is preferred.
  • At least five years of related experience and/or training, or equivalent combination of education and experience.
  • Knowledge of pharmaceutical terminology, medications, quality assurance, and pharmacy operations.



Physical Requirements:

  • Lift/move/push materials from 25 to 50lbs and occasionally lifting/moving materials greater than 50lbs.
  • Work in 62 degrees Celsius or cooler temperatures for entire shift.
  • Remain in confined workspace wearing personal protection equipment such as face mask, gloves, gown, hair net for 4+ hours.
  • Stand for entire shift (8+ hours).



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