Get new jobs for this search by email

QA Specialist -Shop Floor Manufacturing and Packaging Monitoring- Parsippany NJ

Job Overview:

As the Specialist QA, you will be responsible for shop floor monitoring, clearance, and record review during aspects of parenteral manufacturing. This includes, but is not limited to, raw material release, compounding, aseptic filling, lyophilization, inspection, labeling, and packaging.

Responsibilities:

• Monitor production activities for conformance to approved procedures. Identify any deviations or non-conformances during all production activities. Initiate QA-track events as appropriate and monitor investigations for on-time completion.
• Perform AQL sampling and inspection of raw materials, and inspected, labelled, and finished products according to ANSI/ASQ Z1.4 standards and approved procedures.
• Perform batch record review for all production steps – ensure compliance to established and validated parameters.
• Author and/or provide input for new and revised quality procedures.
• Train on and support Controlled (Grade C and D) and Aseptic (Grade A and B) processing areas with Line Clearances, QA oversight, and batch record review (MBR and EBR).
• Obtain and maintain gowning training for Grade C and D, and Gown Qualification for Grade A and B.

Requirements:

• Bachelor’s degree in health sciences with a minimum of 2 years of experience in a quality operations role. Alternatively, candidates may be considered with a total of 8 years of equivalent experience in a quality operations role.
• Previous aseptic gown training preferred.
• Knowledge of sterile operations preferred.
• Knowledge of cGMPs.

Physical Requirements:

• May need to spend extended periods standing or walking to inspect production processes, equipment, and products. The need to bend, stoop, or reach to access equipment or products in different areas of the shop floor is common.
• May be required to wear PPE, such as safety glasses, gloves, lab coats, or respiratory protection.