The Quality Support Center (QSC) Specialist supports the performance and activities within the QSC. He/She assist their management team to communicates the quality policy and objectives are implemented and maintained in alignment with healthcare guidelines (e.g., cGMP, GDP, GMP) and ISO 9001/ISO 13485 requirements. He/She supports the development standard operating procedures (SOPs), reviews and approves work instructions related to their area of responsibility, trains personnel and internal clients on SOPs and regulatory topics. This role supports activities withing the QSC, assesses trends, and communicate recommendations to the next level of management.  

Responsibilities and Duties

• Support his/her Management with the coordination of tasks, design, impact, and/or continuous improvement of the Deviation & Change Control Programs.
• Initiates the investigation and development of deviations and change controls by providing direction for facilitation of improvements on identified risks to field QA.
• Assists with the reviews of policies, procedures, regulations, and specific work instructions.
• Assist with the development set of criteria for trending of quality data for their area of responsibility to assist with performance trending.
• Assists with the development and manages Quality records (e.g., deviations, change control, validation, supplier management, and training) in alignment with the quality policy and processes for consistent change management practices.
• Utilizes evaluation tools to collect data from the electronic Quality Management System (eQMS).
• Designs standardized reports to ensure key performance indicators are measurable.
• Provides support to the field teams for queries funnel through the QSC.
• Recommends changes and/or continuous improvement ideas to the next level of management.

Preferred Competencies

• Experience with healthcare regulations (e.g., cGMP, GDP, GMP) guidelines is preferred.
• Experience with ISO 9001 and ISO 13485 standards is an advantage.
• Good knowledge of English and Spanish (in speaking and writing)
• Knowledge of Quality Management System is an advantage.
• Experience with working with learning management systems (LMS)
• Knowledge of Microsoft Office (Excel, Word, Outlook, Access).
• Captures/documents specific and accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies appropriate details when requested; maintains organized files.
• Identify potential gaps in the processes and make recommendations for possible improvements.
• Strong time management skill, able to work within time-limits (deadlines).
• Flexible in working hours (job may require working outside of 0900 to 1700).

MINIMUM QUALIFICATIONS

• Bachelor's Degree (or internationally comparable degree) – Preferred
• Bachelor's Degree (or internationally comparable degree) – Science or related discipline – Preferred

Before proceeding with the recruitment process, please familiarize yourself with the procedure at the following link: https://ups.pagetiger.com/bdpxpfu