Specialist I, QA Floor (2nd Shift, M-F) Contract to Hire

About the role

Ensures processes and products conform to established company and regulatory standards. Reviews, analyzes, and reports on quality discrepancies related to manufacturing and testing of product and company systems. Investigates problems and recommends disposition and corrective actions for recurring discrepancies. Uses predetermined methods, operations, and procedures to inspect and test raw materials, work-in-process, and finished product as applicable. This is a 2nd Shift position.

Schedule

2:00 PM to 10:30 PM

Responsibilities

• Identify, communicate, and escalate basic technical issues.
• Identify options for resolutions and lead implementation of corrective actions.
• Prioritize own work and work independently on day-to-day activities; additional supervision/guidance for new assignments.
• Serve as point of contact on the manufacturing floor as needed.
• Review executed batch records – real-time remediation to prevent deviation (e.g., GDP, settings, alarm response).
• Perform QA activities in the batch record.
• Verify entries occur in real time in batch records.
• Perform QC/Retain sampling for each batch.
• General observations regarding procedural compliance of staff.
• Observe the gowning and flow of materials and people.
• Review all operations for the batch were performed in accordance with BR.
• Identify, communicate, and escalate compliance issues; identify options for resolutions.
• Perform data entry and execute records in electronic systems.
• Responsible for observing all Company, Health, Safety, and Environmental guidelines.

Requirements

• HS/GED with 2-3 years’ experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 1-2 years related experience, preferably in the pharmaceutical industry, or the combination equivalent of training and experience.
• Knowledge of GxP Compliance and ISO standards.
• Ability to work autonomously to problem-solve, demonstrating excellent analytical skills.
• Excellent written and verbal communication skills.

Physical Requirements

• Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
• Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek® jumpsuit).

Pay

$28.80 - $43.20 per hour