QA Document Control Supervisor (2nd shift) job in Morris Plains
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
PLEASE NOTE: This 2nd shift schedule is a 4 day x 10 hour work week (Wednesday - Saturday or Sunday - Wednesday) from 1 PM to 11 PM or 2 PM to 12 AM.|
Supervise QA Document Control team responsible for two-shift operational execution of batch record and label issuance/control and documentation/records lifecycle management in compliance with cGMP legal and regulatory requirements, the Novartis Pharmaceuticals Corporate Quality Manual and Policies, and site procedures and business requirements.
• Second shift covering evenings and one or both weekend days as required to support operations.
• Supervise QA Document Control personnel responsible for two-shift operational execution of batch record and label issuance/control and documentation/records lifecycle management activities such as creating, issuing, receiving, reconciling, filing, archiving, and providing execution copies in a compliant and secure manner per cGMP regulatory requirements and in accordance with Novartis procedures and Quality Manual.
• Manage the Documentation and Records Centre and Batch Record and Label Issuance Centre to ensure compliance to business procedures and processes and provide direct operational input/support to critical production path over two-shift operation.
• Print and issue batch records, apheresis labels, batch record/sample labels, and final product labels to support operations.
• Enter/maintain information accurately following GDocP, data integrity, and information security requirements to support operations and overall lifecycle of documents and records.
• Oversee off-site records storage in coordination with Novartis Record Management requirements.
• Oversee contingency process and the issuance of manual documentation. Maintain document master and document contingency lists to ensure they are current.
• Lead/support continuous improvement initiatives, creation and revision of procedures, and development of metrics for Document Control.
• Lead/support deviations, investigations and CAPA creations/execution for Quality Compliance.
• Implement and ensure adherence of appropriate regulations, quality standards, and global operating procedures.
• Ensure document management, batch record and label issuance/control SOPs reflect current operations and at a minimum are updated to meet the SOP periodic review requirements
• Support validation/qualification activities as needed (e.g. labeling associated with Cell Chain).
• Present documentation quality systems and provide documentation control support for self-inspections, internal/external audits and Health Authority inspections. Interact with FDA, partner and supplier auditors/inspectors as needed.
• Support regulatory filings as needed.
• Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
Education: BA/BS in Biological Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.
Languages: Fluent in speaking / writing in English
Experience: 6 or more years of professional pharmaceutical experience with two or more years of quality assurance and/or compliance experience preferred. Two or more years in a leadership/supervisory role preferred.