Senior Quality Specialist (Complaint Investigations) – NJ Pharma/Top Dollar Job
Our client, a rapidly-expanding pharmaceutical manufacturer in Northern NJ, seeks an exceedingly sharp and knowledgeable Quality professional to join its growing team. This Quality Specialist will be heavily involved in leading complaint investigations related to third party production. Seek a top-notch Quality professional who enjoys a troubleshooting, point-person role.
Company is thriving. It has multiple products on the market and is expecting to launch several more. It uses third party suppliers for various aspects of its production/packaging process and ensuring that these vendors are delivering product that meets cGMP and Company standards as well as maintain compliant and accurate documentation is essential. This Quality Specialist plays a key role.
Specific responsibilities include:
- Coordinate Complaint Management for the Third Party Complaints life cycle (Receipt, Process, Tracking, Closure) including liaising between suppliers and Corporate Product Monitoring dept to address and respond to customer complaints.
o Track open complaint investigations including any preventative/corrective actions outstanding.
o Follow-up to ensure investigations and preventative/corrective actions are completed in a timely manner.
- Maintain open lines of communication with third party suppliers. Engage vendors in resolution of investigations, complaints, APRs, and batch disposition.
- Collate APR element data and summarize in reports for all third party manufactured products.
- Acts as Company liaison to third party suppliers for document management (Complaints, Batch Records, APRs, etc.)
o Track third party documentation and coordinate internal review/approvals when necessary.
o Compile the information and file appropriate documentation in the vault for storage.
- Assist in a diverse set of activities related to ensuring a continuous, compliant product supply. Work with external manufacturer/packagers and internal groups to support cGMP requirements and Company systems.
Ideal candidate will offer:
- extensive experience in pharmaceutical manufacturing/packaging
- bkgd in the investigation of complaints
- strong knowledge of GMP processes and document standards and practices
- experience working in an outsourced/third party supplier model
- plusses include experience with sterile and transdermal products and SAP QA system
In addition, seek a take-charge candidate who brings the organizational skill and personal leadership needed to guide the investigation process. One who develops positive relationships with vendors and colleagues and has the interpersonal “touch” needed to navigate sometimes delicate situations.
This is a direct hire opportunity and client will pay an excellent wage (including relo) to attract and retain an excellent person. Please forward resume for prompt reply.