• Provides guidance and support to personnel performing deviation investigations and CAPAs.• Review and approve change controls related to Quality topics.• Participates as Quality representative for the implementation of Manufacturing Execution System project.• Develops training on QA-specific procedures and processes. • Delivers training and elevate capabilities of QA members.• Support internal and external audits.• Leads QA team as an SAP subject matter expert.

• Participated in cross-functional teams to provide Quality oversight.• Reviewed and approved deviation investigations and CAPAs associated with cGMP compliance.• Performed batch disposition of raw materials and manufactured materials up to final bulk drug substance and antibody intermediate materials.• Collaborated with key stakeholders to resolve quality issues and discuss batch disposition planning.• Met regularly with functional areas to relay goals and objectives related to batch record review activities to ensure timely disposition of products.• Initiated and led project within QA team to reduce and eliminate backlog of batch records.• Trained and onboarded new QA members.• Performed QA review and approval of controlled documents.

• Performed thorough documentation review with high attention to detail of batch records and quality forms in support of final drug substance batch disposition.• Provided support and guidance on basic and routine quality-related issues.• Reviewed and approved new and revised area documents.• Supported non-conforming activities by initiating deviations, assisted root cause investigations, and quarantined non-conforming product.• Verified raw materials against quality standards and adherence to specification for release.• Generated weekly and monthly quality metric data to analyze in support of continuous improvement.

• Supported the start-up phases of production. Responsibilities included: developing, testing and executing standard operating procedures (SOPs) and batch records (BRs), troubleshooting with engineers, and operating column chromatography.• Supported continuous improvement of the production process by initiating workflows, and authoring and revising downstream SOPs and quality forms.• Ensured equipment was performing as intended and was compliant by performing validation activities, used released and non-expired small parts, and completed documentation of all activities in appropriate quality records.• Increased efficiency and reduced risk of non-conformance by utilizing 5S methodology in downstream workspace areas.

•Worked alongside pharmacists and other technicians to provide excellent customer service in fast paced retail setting•Analyzed and documented prescriptions and insurance information for billing of medications•Resolved dosage conflicts, prior authorizations, and insurance issues to ensure patient safety and wellness•Managed inventory by verifying quantities against invoices, ordering out of stock and pulling outdated medications

•Provided friendly customer service in person and over the phone•Accurately and efficiently packaged food orders•Handled money and customer complaints independently