**_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.