Quality Assurance FFIP First Shift Lead

Job title: Quality Assurance FFIP First Shift Lead

Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to improve processes / procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements. 

Main Responsibilities:

• Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels.

• Coordinate daily floor coverage to ensure appropriate resources are available to complete QA activities.

• Coach other shop floor QA specialists to continually improve and advance the Quality Culture.

• Provide daily floor coverage to support compliance of production, development, and testing of all products within functional areas. Audit areas to ensure compliance with cGMP, regulatory, and internal requirements.

• Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to upper management, recommend appropriate corrective actions when necessary, and perform monitoring with respective functional area management to ensure compliance.

• Obtain environmental monitoring competency

• Ability to obtain and maintain aseptic gown qualification

• Complete risk assessment, non-significant / Significant incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation.

• Manage the CAPA system to ensure that corrective and preventative actions are implemented and completed on time. Provide recommendations to department management regarding CAPA development for process improvements.

• Provide support to functional areas regarding the Change Control System by providing assessments, closure, and monitoring. Recommend documentation and supporting data to be included in the Change Control, so proper assessments of cGMP areas can be evaluated, and risk mitigated.

• Perform batch record review including real-time and electronic batch records

• Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements such as company guidelines and approved procedures.

• Interact successfully within the highly energized production and regulatory environments, to ensure compliance, mitigate risk, and ensure products are safe for patients.

• Interacts regularly with site counterparts relating to manufacturing, testing, disposition, and cold chain documentation. The incumbent must be able to clearly communicate the cGMP requirements.

• Interacts with internal / external auditing bodies. Ability to present / describe / articulate processes, and documentation to auditors may occur.

• Shift is Sunday through Thursday.