Quality Assurance Manager

1 month ago


Fort Lauderdale, United States Park Avenue Group Full time

Park Avenue has partnered with a private pharmaceutical manufacturing organization in South Florida to find an experienced Quality Assurance Manager.


Key responsibilities include:

  • Collaboration: Share responsibilities with the Production Manager within the facility.
  • Team Oversight: Manage the QA and sterile boxing teams, consisting of approximately 40 staff members.
  • Regulatory Compliance: Ensure compliance with state and federal regulations and accreditation agencies governing pharmacy practice.
  • Subject Matter Expert: Act as the on-site expert for inspections and assist with required documentation.
  • Process Improvement: Recommend improvements for QA processes, systems, and department operations.
  • Document Management: Maintain regulatory documents, ensure assessments and training are updated, and organize master formulation and compounding records.
  • Stability Studies: Conduct stability studies on new medication products.
  • Safety and SOP Compliance: Ensure staff adherence to laboratory SOPs, safety policies, and procedures, including proper use of personal protective equipment.
  • OSHA Training: Assist in coordinating and tracking OSHA training for staff.
  • Customer Feedback: Keep records of customer complaints, reactions, and feedback on medication products.
  • Site Monitoring: Operate the site monitoring system to ensure adequate temperature control.
  • SOP Development: Create and maintain all departmental SOPs.

Work Schedule: This position is ONSITE, Monday to Friday.


The qualified candidate will have the following:


Communication Skills:

  • Ability to convey complex technical information to a variety of stakeholders, including customers, senior management, and production personnel.
  • Excellent verbal and written communication skills.
  • Strong interpersonal and customer service skills.

Attention to Detail:

  • Keen ability to recognize defects and inefficiencies in products and procedures.
  • Essential for evaluating and upholding company standards.

Leadership:

  • Provide direction, motivation, and guidance to quality improvement efforts.
  • Strong supervisory and leadership skills.
  • Demonstrated success as a team leader.

Analytical and Problem-Solving Skills:

  • Ability to analyze every detail to ensure maximum product quality and safety.

Time Management Skills:

  • Ability to meet deadlines efficiently.

Education and Experience:

  • Bachelor’s degree in a related field, such as business or engineering.
  • Three to five years of experience in a quality assurance environment.
  • Supervisory experience is a plus.
  • Requires current or prior experience with Sterile/Injectable medications & equipment.



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