Our client, a leading Pharmaceutical company is hiring a Senior Specialist, QA Operations on a contracting basis.
Work Location: Warren NJ
- Responsible for quality oversight of Cell Therapy Development Operations
- Functional responsibilities include On-Site coverage/participation in QA Shop Floor and QC Laboratory Walkthrough activities, Label Printing and Issuance of finished drug product and shipping labels, Event Triage including Deviation and CAPA QA Review and Approval, Packout oversight and performing market release, ensuring accurate and timely review and maintenance of clinical manufacturing GMP/batch related documentation and procedures
- Provide Functional QA Oversight of Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
- Participate in Shop Floor and QC Laboratory Walkthrough programs
- Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations
- Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints
- Revise department SOPs, as well as, Review and QA Approval of CTDO SOPs
- Perform Real time review /approval of executed batch records and Chain Of Identity verification
- Responsible for ERP Material Status Changes of production/drug product
- Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements
- Supports Risk Assessments/projects as required by senior management.
- Must have advanced knowledge and Quality experience with cGMP manufacturing US and global requirements
- Must possess an independent mindset and have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles
- Must be skilled in planning and organizing, decision-making, and building relationships
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
- Seeks management guidance on complex issues
- Follows established procedures and performs work as assigned
- Develops procedures as needed
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
- Proposes solutions for complex issues and works with management to resolve
- B.S. scientific discipline or relevant college / university degree preferred
- Minimum 5 years cGMP work experience with minimum 2 years of Quality experience
- Strong knowledge of cGMP Quality And Compliance principles required
- Clinical and Phase appropriate experience preferred
- Strong cross-functional collaboration experience required.
Please contact me directly if you are interested in learning more about this opportunity or to discuss our referral program if you know anyone that may be interested.