Quality Assurance Senior Specialist

Feedback from Hiring Manager intake call:

• What location will this role be tied to? 100% remote role, preference is eastern time zone. But EM is open to other time zones.
• What are the exact shift hours/schedule the contractor will be working/reporting? Mon-Friday standard business hours 8-5 PM
• What is the working environment for this role? Role supports quality management systems, office based, EW will be supporting recall regulatory reporting 50% of their time and other projects for the QMS team for the remainder of the time.
• What type of qualities/characteristics are you looking for in candidates to work best with your team? Looking for a candidate who is comfortable working remotely and able to work independently, understanding quality management systems (QMS systems), looking for a candidate who has experience in the pharmaceutical industry, candidate will need ability to navigate a fast paced environment, need an individual who has the ability to communicate with all levels of an organization (ability to adapt their communication to this).
• When reviewing resumes, what stands out to you when looking for the right applicants?
  
  

○ Need a candidate with experience in QMS

○ Minimally with 5 years of experience with QMS executions and deviations.

• What is your minimum education and work experience requirements you think it suitable for this role? Candidates to meet the BQ for education, but need a candidate with strong work experience and able to speak with this experience in detail during the interview.
  
  

Responsibilities: Primary focus is the support and oversight of ***’s Quality Management Systems ensuring key requirements and initiatives are implemented, maintained and reviewed in accordance with cGMP regulations. Additional detail responsibilities, accountabilities or decision authorities are defined in procedures to execute assigned task for the role and deployed through assignment of procedure training in the Learning Management System. Responsibilities could include:

• May be responsible for leading and directing the Quality functions for assigned plant(s) or functional area(s)
• Responsible for providing Quality oversight to ensure that ***’s systems are executed, according to current Good Manufacturing Practices (cGMP) and other applicable regulations
• Ensures that Quality Management Systems comply with cGMP practices and other applicable regulations
• Provide support for Global Process Owners executing key quality systems processes
• Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including nonconformances, CAPAs, change control records and validations. May execute these tasks
• Supports Continual Improvement initiatives, programs and projects
• Ensures that changes that could potentially impact product quality are assessed according to procedures
• Ensures that deviations from established procedures are investigated and documented per procedures
• Collect and analyze Key Process Indicator (KPI) data to assessing process performance and areas of improvement
• Alerts senior management of significant quality, compliance, supply and safety risks