Responsibilities:
- Supporting the product complaint system; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
- Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
- Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
- Follow-up on corrective actions derived from investigations through completion.
- Possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
- Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
- Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
- Bachelor's degree in related area
- Five (5) years of directly related experience to the job
- Experience in project management, root cause analysis, and Corrective and Preventive Action (CAPA) determination and implementation.
- Strong quality mindset with comprehensive knowledge of quality systems, cGMP compliance, and regulatory requirements.
- Proficiency in Microsoft Office Suite, including Excel and Outlook.
- Experience using Microsoft Teams for communication, collaboration, and cross-functional meetings.
- Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a regulated environment.
- Administrative Shift
Skills Required
- Bachelor's degree in a related area
- Five years of directly related experience
- Experience in project management
- Experience with root cause analysis
- Experience determining and implementing Corrective and Preventive Actions (CAPA)
- Comprehensive knowledge of quality systems
- Knowledge of cGMP compliance and regulatory requirements
- Proficiency in Microsoft Office Suite, including Excel and Outlook
- Experience using Microsoft Teams
- Strong analytical, organizational, and problem-solving skills
- Ability to manage multiple priorities in a regulated environment
- Availability for an administrative shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
