Quality Analyst - QA Operations (Night Shift)

The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You will be responsible for investigations and escalation on the floor in a timely manner to continue uninterrupted production. You will be responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities include and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as an SME for processes.

·         Responsible for sample management (Sterility, stability, etc.) to appropriate facilities and responsible for the appropriate storage and disposal of retention samples.

·         Complete investigations in the event of a failure pertaining to processes or Raw Material that is deemed to be out of specification.

·         Triage potential issues on the floor. Initiate deviation and complete investigation, if required.

·         Revise documents to procedures, forms, and specifications as needed.

·         Manage the appropriate storage and disposal of retention and reserve samples.

- Identifies and assesses quality risk in production operations daily. QOTSF review of checklists and trending of observations for monthly quality council. QOTSF program management and JDE work order initiation if required.

·         Perform Returned Goods, Product Holds, and Tagging and Untagging of non-conforming material in a timely manner.

·         Responsible for movement of materials/products physically and electronically for quarantine/reject areas and trained on PIT/forklift to move materials.

·         Review and release pre-printed materials to manufacturing following cGMP procedures.

·         Collect and submit rinse and bioburden samples to a laboratory.

Oversee Manufacturing support activities, including batch record documentation review, approval of OSI PI Reports, scanner card management, label copy control and issuance.

·         Ensure pre-printed material label cage is maintained in a GMP state at all times while following all EHS and 5S guidelines.

·         Operate and proactively maintain quality operations equipment. Ensure that equipment maintenance is properly documented in a timely manner.

·         Support execution of conformance protocols with appropriate training

·         Serve as Subject Matter Expert (SME) and provide training to other members as required.

·         Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.

·         Monitor product quality through the performance of required visual and functional testing.

·         Actively contribute to a team setting within the quality operations and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.

• Support regulatory audits as required.

• Highly effective verbal and written communication and great attention to detail.
• Good problem-solving skills.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.
• Able to work with JDE, EBM, TW workflows, Systech, and other LMS/DMS.