Job Description

The Regulatory Compliance Coordinator position is responsible for the support and maintenance of regulatory compliance functions for the organization in a 24/7 high speed atmosphere. Reports to Senior Manager of Regulatory Compliance.

**POSITION SUMMARY: **

The focus of the position is to support the performance and hosting of audits, update and revision of policies and procedures, completion of investigations and CAPAs, processing of change controls, management of documents, handling and investigation of customer complaints, and performance, management and recording of training.

ESSENTIAL FUNCTIONS:

The Regulatory Compliance Coordinator plays a key role in identifying gaps in programs or processes and assuring the QA team assists in closing those gaps. Main responsibilities include:

• Responsible for assisting the oversight and management of regulatory compliance functions for the site.
• Understanding of various Quality system regulations (21 CFR Part 111, 210, 211, and 820)
• Support the performance and management of Quality Management System (QMS): audits, policies and procedures, investigations and CAPAs, change controls, document management, customer complaints and training.
• Aid in ensuring the Quality Management System (QMS) is in accordance with client and company requirements and regulations.
• Provide support to the company during regulatory and client inspections/audits.
• Performs data entry and analyses of metrics to identify trends as well as areas of immediate concern and escalates to management attention, as necessary. Responsible for assisting in scheduling and execution of the site internal auditing program and assuring CAPAs are completed in a timely manner.
• Actively participate in company continuous improvement initiatives.
• Able to work in an environment of rapidly changing priorities and workload.
• Support, aid and assist Document Control, Batch Record creation, Batch Record Review and Release, as required.
• Provide general support to all Quality Assurance functions across the organization.

**JOB SPECIFICATION: **

This position requires minimum B.S. degree or other related 2-5 years QA experience in regulated industry. Knowledge/experience in conducting quality system assessments for manufacturing/packaging locations and suppliers. Knowledge of packaging systems. Excellent computer skills, to include spreadsheet, database, and word processing applications. ERP systems, a plus. Excellent verbal and written communication skills. This individual must have the ability to share their technical knowledge with others in a coaching environment to ensure compliance with Nutra-Med SOP’s.

Nutra-Med Packaging, LLC. , is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. We make hiring decisions based solely on qualifications, merit, and business needs at the time.

If you're ready to take your career to the next level and be part of a team that values excellence and integrity, we encourage you to apply for the Regulatory Compliance Coordinator position today!

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