Quality Associate- Quality Operations

Responsibilities

• Provides direction and guidance to daily QA and Production activities.
• Audits production batch records throughout the packaging process for accuracy and compliance.
• Conducts final audit prior to submitting to Product Release.
• Performs serialization activities, including but not limited to sending print, releasing, suspending, and cloning a work order to support production needs.
• Verifies and corrects non-controlled product and packaging component discrepancies within the applicable systems.
• Ensures applicable deviations and supporting documentation is provided in the batch record.
• Performs Quality in-process checks as needed.
• Performs Specific Gravity testing and TOC analysis.
• Performs Cleaning Validation swabbing upon the request of the Stability department.
• Creates, Reviews and Updates WIs and SOPs applicable to daily activities.
• Escalates non-conformance issues during the production process to management and leads the root cause analysis of quality incidents, participates in investigation discussions, and drafts Unplanned Deviations prior to submitting it for management review.
• Actively engages in all technical training, as well as compliance and other training required as a member of the quality team.
• Works in partnership with supporting areas (Sampling, Label and Documentation, Production, Warehouse) to resolve issues and improve processes by participating in continuous improvement activities to increase efficiency and Team Member engagement in the production area.
• Participates on the site internal audit team representing QA Production.
• Adheres to all cGMP, safety regulations, and understands SOP's.
• Performs all other duties as assigned.

Requirements

Completion of a high school diploma, general education or GED is required.

The work environment is generally noisy in the warehouse; reasonable accommodations may be made for individuals with disabilities.

Physical demands