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.
