Quality Assurance Specialist

Quality Assurance Specialist
Contract - 12 months

Location: Remote or Onsite (dependent upon location of candidate)
 

Reports To

Director, US Patient Safety Quality & Enablement


 

Brief Job Description

As a member of the US Patient Safety (US PS) Quality & Enablement Section, the Quality Assurance (QA) Specialist is responsible for the Product Quality Complaint (PQC) processes, including supply site liaising and case escalation/resolution. Key elements of the position are US complaint process and regulatory knowledge, customer service, teamwork, and process improvement..


 

Typical Accountabilities/Responsibilities

• Conducts activities and interactions consistent with organizational values and behaviors and in compliance with the Code of Conduct and supporting policies and standards relevant to the role. Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes. Reports potential issues of non-compliance.
• Serves as a knowledge resource to staff with a deep understanding of organizational global and local procedural documents and local implementation of objectives, policies, processes and procedures and regulatory requirements, guidelines and obligations relevant to PQCs for medical devices and delivery systems (e.g. injectables, inhalers). 
• Conducts a range of QA activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.
• Performs the tasks of the US PQC process to ensure consistent, clear, effective, and timely identification and communication of all PQCs to the appropriate investigation supply sites.
• Responds to supply site inquiries regarding PQCs and follows up on supply site inquiries with customers as needed.  Manages customer interactions to successful resolution.  Obtains pertinent customer information and record customer interactions in appropriate systems.  Meets AZIC quality and customer satisfaction standards.
• Maintains a high level of understanding of relevant quality systems.
• Remains current with evolving regulatory compliance and quality practices related to PQCs.

Essential Qualification:

• Qualified to degree level preferably in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering or an equivalent pharmaceutical industry quality assurance background.
• Minimum of 2 years of quality assurance experience, to include knowledge of cGMPs, quality systems, and the pharmaceutical supply chain environment including a solid understanding of FDA and other Health Authority regulatory requirements, guidance and obligations.
• Proven analytical skills
• Proven leadership skills
• Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures.
• Demonstrated ability to manage multiple competing assignments and timelines.
• Fluent in English language with excellent communication skills, both oral and written.
• Demonstrated ability to influence whilst maintaining independent and objective views.
• Demonstrates ability to maintains high ethical standards, including a commitment to organization values and behaviors.
• Detail oriented.
• Computer literate.

Desirable Requirement:

• Advanced degree in Quality Assurance/Regulatory Affairs and/or professional certification (project management, Lean Six Sigma, American Society for Quality (ASQ) Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/ Organizational Excellence, or Society of Quality Assurance (SQA)
• Registered Quality Assurance Professional (Minimum 3 years of Quality Assurance auditing experience).
• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
• Extensive experience in a pharmaceutical quality assurance environment
• Experience with medical devices and delivery systems (e.g. injectables, inhalers)
• Multi-site / multi-functional experience
• Project management expertise
• Previous experience in a call center environment
• Demonstrated ability to lead without authority

LS Solutions is a privately owned minority certified niche consulting and managed solutions firm head quartered in Princeton, NJ servicing Life Sciences industry with international office locations in India, Singapore, Germany, Belgium and United Kingdom.