Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Specialist Quality Complaints

Primary responsibilities include: Supporting the product complaint system through; 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.

Qualifications:

• Science or Engineering degree:
  • Doctorate degree or
  • Master's degree and 3 years of directly related experience to the job or
  • Bachelor's degree and 5 years of directly related experience to the job or
  • Associate’s degree and 10 years of directly related experience to the job
• Experience with:
  • investigations
  • Root Cause Analysis
  • Complaint investigations
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Ability to oversee multiple projects simultaneously
• Ability to successfully manage workload to timeliness
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes)
• Ensures quality of complaint records, consolidated / trend investigations
• Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Executes against prioritized work plans
• Quickly escalates issues that cold impede the ability to close records according to action plans
• Maintains compliance with local and global processes
• Follows procedures and regulatory requirements
• Reviewing and acknowledging information contained in product complaint records
• Determining if additional information is required to assign appropriate investigation requirements
• Determining if return samples are required and following its status
• Reviewing and approving assessments supporting the investigation
• Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event
• Completing historical data analysis and trend evaluation assessments
• Voiding records if required
• Completing customer feedback records if required
• Own consolidated/trend investigations until closure, if required
• Software: Trackwise, Excel, Word, Microsoft office.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Available to work extended hours, possibility of weekends and holidays.