Provide Quality assistance and oversight during QC processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of all cGMP documentation and source data complies with all applicable cGMP regulations, Good Documentation Practices and Data Integrity Guidelines.
Provides QA oversight to QC operations.
Performs routine QC record review in support of product release in accordance with cGMPs, specifications and SOPs.
Support QC Laboratories and manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.
Reviews documentation associated with QC and production operations to assure that data integrity is maintained. Ensures adequate levels of documentation are acceptable and cGMP compliant to existing procedures.
Review and audit QC documentation and production batch records to ensure adherence to Immunomedics policies, SOPs and cGMP requirements.
Provide support to QA Batch Release to assist with batch record release and documentation issues.
Initiate deviation reports and participate in activities for issue resolution and CAPAs.
Participate in process improvement initiatives targeting for Right-First-Time (RFT) on documentation.
Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to implement corrective actions.
Implements and ensures adherence of appropriate cGMP regulations, Good Documentation Practices and Immunomedics quality standards.
Reviews and evaluates any documentation that is to be shredded to assure that no original or source data is destroyed.
Write, review and approve Standard Operating Procedures (SOPs), as needed.
Support operations to encourage a Quality Culture and ensure a safe working environment.
Complete job-related training as required.
BS/BA in Biological Sciences or equivalent relevant career experience.
3 + years of experience in a Pharmaceuticals environment.
Knowledge and practical understanding of cGMPs, Good Documentation Practices and Data Integrity Guidelines.
Excellent written and verbal communication skills required, including Responsible Business Communication.
Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
Must be proficient with MS Office applications.