Lead QC Associate - Incoming

Purpose and Scope

The Lead QC Associate - Incoming provides leadership and guidance for the Incoming inspection team.  This includes scheduling/coordinating inspections, ensuring timely releases of materials, troubleshooting issues and performing inspections/material releases.  The Lead QC Associate - Incoming helps to drive continuous improvement initiatives for the team. 

Essential Duties & Responsibilities

• Inspect incoming materials, components, and finished product against specified requirements.
• Perform associated testing of incoming materials including labels, cartons, syringes, containers etc.
• Utilize measuring and testing equipment to evaluate product measurements.
• Document all results per cGMP, ALCOA+ and data integrity policies and procedures.
• Reviews COAs for all incoming materials, including APIs and excipients for compliance to the specification prior to the release of materials in the ERP for use in production.
• Prioritize daily group tasks, including scheduling of material inspections to ensure timely inspection, sampling and release of material.
• Communicate with the planning team regarding material needs and timelines.
• Perform inventory requisitions for requesting departments.
• Place materials on hold in ERP related to deviations and for expired materials.
• Determine which materials should be placed in a rejected status.
• Determine which materials require retesting.
• Perform inspection of all controlled supplies ensuring integrity and sterility.
• Review logbooks, and documentation to support room cleans.
• Identify and support improvements to streamline inspection and documentation processes and work with other departments involved to ensure success.
• Attend T3 academy.
• Perform required CBTs, annual data integrity and safety related training and cross train on all associated job functions to ensure adequate process coverage.
• Complete compliance training according to requirements and maintain training records in the electronic document system.
• Contribute to Competency Based Training (CBT) as a subject matter expert, acting in a Developer, Trainer and Assessor capacity.
• Update and review SOPs, specifications and work instructions using the electronic document management system.
• Provide quality support to associates for troubleshooting issues and escalate as required.
• Act as a lead or SME on investigations involving QC Incoming activities or processes.
• Coordinate monthly quality and safety walkthroughs.
• Initiate deviations, complete immediate actions and request assessments for non-conformances from appropriate groups (i.e. Packaging Engineering).
• Complete corrective and preventative actions as determined through investigations.
• Follow procedures to determine status or disposition, and properly document results on records and in laboratory notebooks.
• Support Materials Management (Receiving and Issuance Personnel) with inspections and material sampling.
• Ensure proper status and storage of materials and products.
• Provide materials to outside departments supporting status requests as needed.
• Collect and dispose of retain samples in accordance with procedures.
• Perform cleaning and monitoring of rooms and equipment.
• Coordinate equipment calibration with Calibration team.
• Demonstrate high level of proficiency in department job functions.
• Provide recommendations for quality decisions related to incoming inspection.
• Perform cross training in other QCC systems, processes and procedures including but not limited to laboratory support, sample submission, logbook creation, inventory maintenance, ordering and glassware cleaning.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities 

• Working knowledge in drug or device cGMP.
• Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
• Ability to learn Tolmar electronic systems (ERP, EDMS, EQMS and ELMS).
• Strong organizational skills and attention to detail.
• Strong written and oral communication.
• Ability to work well with employees at all levels and departments.
• Ability to read, understand and follow procedures.
• Strong technical writing skills.
• Ability to use critical thinking to address non-conformances and potential areas of concern.
• Ability to work independently and properly prioritize tasks with limited supervision.
• Ability to identify non-conforming materials, processes and procedures.

Core Values

The Lead QC Associate - Incoming is expected to operate within the framework of Tol