Quality Assurance Specialist

The Fountain Group; Philadelphia (Philadelphia County); On-site; USD 48,739 - 54,842; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Specialist in Philadelphia. This role involves real-time oversight of the FluMist/Fluenz Packaging operation, ensuring quality compliance and GMP adherence. The ideal candidate will have a Bachelor's degree in a relevant science or technical field and experience within the pharmaceutical industry. Responsibilities include AQL sampling, oversight of packaging operations, and collaboration with production staff.

Qualifications

• Essential experience in the pharmaceutical industry covered by GMP oversight is required.
• Strong communication skills necessary to collaborate effectively.
• Mathematical proficiency to carry out sample size calculations.

Responsibilities

• Perform AQL Sampling and inspection of final product containers.
• Monitor the line during packaging operations for compliance.
• Conduct line clearance inspections during changeovers.

Skills

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

Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering

Job description

Overview

Pay: $35.38 - 39.81/Hour

Shift options:
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.

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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