Manager, Quality Assurance – FFF Enterprises, Inc. – Temecula, CA, USA
The position has oversight and authority over all policies, procedures, systems and equipment that have the potential to impact, both directly and indirectly, our ability to protect and maintain the quality of pharmaceutical products when conducting warehouse and distribution operations. The responsibilities of this position apply across FFF’s network of distribution centers.
Principal Accountabilities: Establish and maintain a documented Quality Management System (QMS) to ensure pharmaceutical product quality is maintained at all times during the course of warehouse, distribution and transportation activities.
Establish and maintain a system for deviation management and corrective action/preventative action (CAPA) as it relates to pharmaceutical product quality.
Responsible for coordinating and overseeing initial and ongoing qualifications (IQ/OQ/PQ) and associated temperature mapping procedures for all pharmaceutical product storage areas.
Accountable for coordinating and overseeing the installation and ongoing maintenance of temperature and humidity monitoring equipment and excursion alarms for all pharmaceutical storage areas. This responsibility includes developing contingency plans to prevent product loss, in the event of an equipment failure. This responsibility applies to FFF and NuFACTOR operations.
Support the organization through the design and thermal/physical qualification of packaging systems required to ensure temperature sensitive products are protected in transit if/when subjected to various seasonal ambient temperature conditions. This responsibility includes coordinating ongoing performance qualification procedures and, as needed, modification of packaging design, test protocols, temperature profiles, temperature requirements, etc. This responsibility applies to FFF and NuFACTOR operations.
Responsible for maintaining, including additions and revisions, FFF’s Operations standard operating procedures (SOP’s).
Oversee the completion of periodic internal audits on Operations to ensure compliance with established quality related policies and procedures.
Participate with Operations and Regulatory Affairs in quality/operations audits conducted by regulatory agencies, vendors, customers, etc.
Ensure Operations maintains compliance with supplier and/or customer quality agreements.
Develop and maintain Operations related quality agreements with various service providers, i.e. transportation companies, reverse distributors, pharmaceutical disposal companies, etc.
Participate in Quality Improvement Program (QIP) meetings and contribute to the team’s efforts of continuous process/quality improvement.
Support the organization with inquiries, both internal and external, related to packaging and product quality.
Continuously strive to improve processes, service quality to internal and external customers and employee relations.
Comply with the policies and procedures stated in the Injury and Illness Prevention Program by always working in a safe manner and immediately reporting any injury, safety hazard, or program violation.
Ensure conduct is consistent with all Compliance Program policies and procedures when engaging in any activity on behalf of the Company. Immediately report any concerns or violations.
Display dedication to the positions responsibilities and achieve assigned objectives.
All other duties as assigned.