Kelly Science and Clinical FSP is currently seeking a Records Reviewer for a long-term engagement in Raynham, MA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Summary:
Responsible for ensuring company products comply with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. This includes activities related to Inspection and Testing, Batch Release and Records Management.
Batch Release and Records Management
Audits batch records to ensure compliance with policies, procedures and regulations.
Ensures batch records are complete and accurate, with all NC's dispositioned prior to release.
Identifies, records and reports on batch non- conformances and product holds.
Stores and maintains batch files either physically or electronically based on established guidelines.
General Responsibilities: • Applies principles of Good Documentation Practices. • Executes assigned NR actions within the applicable software application. • Provides metrics and updates on executions. • Maintains training records up-to-date. • Use of computer-based applications to manage: Inventories, Batch records, Communication, Inspection equipment, Inventory equipment
Skills & Experience:
Experience in auditing/reviewing/ Inspecting in a manufacturing environment
Familiar with GDP (Good Document Practice) or GMP (Good Manufacturing Practice)
Microsoft apps (Excel)
Must be open to overtime as needed
Must be a seasoned worker who is professional and takes direction well.
Must be a team player and flexible with work assignments.