Website The Fountain Group LLC
The Fountain Group LLC
Company : The Fountain Group LLC
Pay: $35.38 – 39.81/Hour
1st Shift: 5:45 – 4:15 (Tue-Fri)
2nd Shift: 3:45 PM – 2:15 AM (Mon – Thu)
Job Summary:
This role provides real time Quality oversight during the FluMist/Fluenz Packaging operation.
The Quality Specialist is responsible for QA On the Floor support to the Packaging 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 AQL Sampling, inspection, line monitoring and cleaning confirmations.
Role and Responsibilities
• AQL Sampling and inspection of final product containers and packaging.
• Oversight of Packaging Operations through line monitoring.
• Line clearance inspections during the changeover process.
• Adhere to PPE gowning guidelines
• Review documents for Good Documentation Practices
• Maintains a high level of understanding of relevant production processes and
quality systems.
• Collaborates with Packaging 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.
• Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on
time.
Skills and Experience
Essential:
• Experience in pharmaceutical industry in roles covered by GMP oversight.
• Excellent oral and written communication skills
• Ability to perform mathematical calculations to determine sample size and acceptance criteria.
Education/Certification
• Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering
Desirable:
• Knowledge of Data Integrity
• Lean Manufacturing
• Previous AQL experience
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