Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering
Experience in pharmaceutical industry in roles covered by GMP oversight.
Experience with aseptic techniques
Excellent oral and written communication skills
Demonstrates ability to work independently and within a team environment
Ability to speak up when something is wrong
Strong Interpersonal skills
Possess strong computer skills
Job Description:
This role provides real time Quality oversight during the FluMist/Fluenz Formulation Filling operation of LAIV.
The Quality Specialist is responsible for QA On the Floor support to the Formulation and Filling Operation. They ensure operations are executed in accordance with cGMPs; makes real time decisions on GDP, GMP and quality compliance issues and partners with production to ensure that processes are carried out in compliance with approved standards. Primary responsibilities include executing personnel monitoring within the aseptic processing, environmental monitoring of finished drug product and documenting any GMP activities performed.
ROLE RESPONSIBILITIES
Provide QA oversight of aseptic processing
Execute personnel monitoring within the aseptic processing area using MODA system
Execute EM sampling and inspection of finished drug product
Conduct real time review of logbooks, and other associated GMP documents
Support quality investigations
Maintains a high level of understanding of relevant production processes and quality systems.
Collaborates with Formulation Fill personnel and other Quality professionals to ensure consistent application and execution of key quality systems.
Executes QA processes to maintain the flow of products and documents to meet site objectives.
Ensures that training is up to date and all tasks are completed per SOP or other defined standard.
Uses lean principles to make suggestions on opportunities to reduce waste and improve processes in Quality Operations.
Report potential issues of non-compliance.
Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.
Other tasks and responsibilities may be assigned as needed.