The Quality Management Systems Associate ensures quality and compliance of the facility with applicable regulatory requirements. These activities may include reviewing documents and data, conducting systems or process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analyses and reporting metrics where required, as well as performing quality / compliance training, as needed. Provide support during regulatory inspections. Assists with the development of SOPs, specifications, and other quality document control activities as needed.

This position’s responsibilities will include, but not be limited to the following:

• Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices including but not limited to sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation) and adherence with applicable safety requirements. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness.
• Perform regularly scheduled, formalized internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations.
• Review SOPs, Specifications, Batch Record Documentation.
• Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and Guidelines and present to the Quality Council.
• Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recall, OOS and Outliers) to ensure compliance with procedures and assurance of due date requirements.

On Site Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.