Summary:
One of the largest global pharmaceutical companies focused on pediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis is looking to bring on an experienced QA Consultant to join the team based in Somerset, New Jersey. This role will review and execute all actions including revision of SOPs, revision of master batch records, issuance, and execution of protocols, and assist with any other actions necessary to ensure closure of open or overdue change controls, CAPAs as well as revise SOPs in Manufacturing, Packaging, Engineering, Warehouse and Laboratory areas. This is a 6+ contract with possible extensions and/or conversion to FTE.
Responsibilities:
- Work together with subject-matter experts from various cross-functional departments to collect documents and information necessary to ensure closure of open or overdue CCs and CAPAs.
- Initiate revisions to appropriate master documents such as master batch records, SOPs, Checklists, Methods, and Specifications.
- Support the execution of all other tasks needed to close overdue Change Controls and CAPAs.
- Other cross-functional duties as assigned.
Requirements:
- Bachelor's Degree in a scientific or technical field.
- 5+ years of pharmaceutical industry experience.
- Cross-functional experience in Manufacturing, Packaging, Engineering, Technical Operations or Laboratory is desired.
- Proficiency in Electronic Quality Management Systems, ERP systems, and MS Office software.
