We are a national staffing firm and are currently seeking a Quality Assurance Specialist for a prominent client of ours. This position is located in Philadelphia, PA.

Details for the position are as follows :

Shift & Compensation :

1ST SHIFT : Monday - Friday from 6am-2 : 30pm

1-3 years of experience $35.38 an hour

3-5 years of experience $37.60 an hour

5 years of experience $39.81 an hour

2ND SHIFT : Monday-Friday from 2pm-10 : 30pm (10% differential)

1-3 years of experience $38.92 an hour

3-5 years of experience $41.36 an hour

5 years of experience $43.79 an hour

3RD SHIFT : Sunday-Thursday from 10pm-6 : 30am (15% differential)

1-3 years of experience $40.69 an hour

3-5 years of experience $43.24 an hour

5 years of experience $45.78 an hour

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.

Roles and 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 role

Other tasks and responsibilities may be assigned as needed

Qualifications : BS / MS

BS / MS

1 year of GMP experience (pharma preferred)

QA oversight experience

Aseptic Technique

Last updated : 2024-02-24