Quality Assurance Specialist in Device Assembly and Packaging
This role is responsible for providing daily quality oversight at a Contract Manufacturer (CM) site. The Quality Assurance Specialist will be located on-site at the CM site, majority of the time, and will help set up processes for device assembly and packaging, supporting technical transfers until process validation.
The Quality Assurance Specialist will provide assistance and guidance during routine manufacturing, addressing issues such as deviation investigations, change control proposals, procedure/master formula revisions, and other daily CM activities.
This role may also be responsible for final disposition of manufactured and/or packaged drug product batches. The Quality Assurance Specialist will serve as the primary contact to the CM for initial escalation and work with the Joint Process Team (JPT) to ensure timely responses for requests for information. They will ensure that batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with current Good Manufacturing Practices (cGMP) requirements and regulatory requirements.
Main Objectives/Deliverables:
- Understand the process and equipment for their product scope, including understanding the science behind the process and equipment to ensure compliance-based decisions promote ongoing effective and efficient processes.
- Be aware of how upstream/downstream processing is affected by their process steps.
- Know the Operational Control Strategy (OCS) and failure modes of the process.
- Be familiar with historical deviations/gaps, trends, and audit history of the process.
Key Responsibilities:
- Support the CM in developing the quality system and process for device assembly and packaging.
- Level, review, and approve event investigations and changes.
- Ensure implementation and effectiveness of corrective and preventative actions.
- Review that practice matches procedure.
- Ensure the CM's quality systems are compliant with applicable GMPs, quality standards, and any additional local market requirements.
- Contribute to quality culture efforts at both DPEM and CM.
- Spend time in all unit operations, including the laboratory.
- Provide primary oversight and guidance for minor investigations and change controls (initial notification and consultation).
- Support onsite resolution of product-related issues.
- Ensure compliance to data integrity (i.e., perform audit trail reviews).
- Perform trouble shooting for in-process issues and escalate as needed.
- Review and provide approval for CM procedure changes.
- Write protocols for non-routine testing or validation with appropriate guidance.
- Participate on Joint Process Teams (JPT).
- Review, enter, or SPV analytical data and escalate as needed.
- Ensure batches are identified and appropriately sampled for annual stability requirements.
- Provide on-site support for GQAAC audits and Regulatory inspections.
- Review and approve complaint investigations.
- Consult on Master batch record updates; provide input based on observations and interactions on the floor.
Metrics Tracking:
- Assist in gathering data to complete the CM's Site Compliance Reports (SCR); provide review as needed.
- Perform internal notification of quality issues where needed.
- Serve as a liaison between the CM and JPT.
- Ensure that materials and products manufactured at CMs are released in compliance with marketing authorization requirements and all applicable GMPs for the intended market.
- Participate in CM performance reviews (Ex IOPs, supply management...etc.).
- Track and monitor quality metrics for trends at the CMs.
- Support batch release activities by completing batch record review reporting any issues. Determine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations. Originate and investigate deviations associated with batch records discrepancies, stability issues, atypical and out of trend results for either chemical, micro or device test (if applicable). Work with Lilly support groups to resolve product-related issues (such as IDM, PDS, GQAAC, Parenteral network). Create Certificates of Analysis or other similar documentation for internal and external customers as needed. Maintain material management (e.g., check all API restrictions in SAP and apply those restrictions to finished product). Provide support for Notification to Management data gathering. Provide input for metrics reports to management. Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external customers.