Quality Execution Coordinator

Quality Execution Coordinator

Position Summary:

The Quality Execution Coordinator is an integral member of the Quality Department who oversees and manages the prompt and effective execution of quality activities. This position supports the Quality Department by helping to bridge the communication infrastructure between the various subunits of the Quality System and by ensuring accountability for the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and fostering continuous improvement are the key objectives. This challenging and unique-in-the-industry position builds on an experienced paralegal or legal assistant’s analytical, organizational, time-management, and investigative skills and offers an exceptional gateway to the fascinating world of fast-paced pharmaceutical manufacturing. The Quality Execution Coordinator will gain unprecedented access to Company’s senior management and become an integral part of building the quality infrastructure in a uniquely Exela way.

Job Responsibilities:

· Reviewing FDA-issued regulations and Guidance documents, as well as drafting, editing, and reviewing internally developed technical documents, such as Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations.

· Aiding members of the Quality Department in developing and maintaining efficient and effective means of communication between the various subunits of the Quality Department and external constituents.

· Assisting Quality Department personnel in identifying and triaging quality issues and initiatives, aiding in the development of efficient strategies for addressing those issues, and then managing the execution of those responsibilities.

· Developing and fostering a culture of time and resources consciousness through coaching time management, issue triage and prioritization, and accountability.

· Enabling and mentoring Quality Department members to provide regular updates on the status of the responsibilities of the various sections of the Quality Department.

Required Skills

· Exceptional writing and research skills.

· A strong ability to interpret and understand complex and technical documents, such as regulations, statutes, and regulatory guidance documents.

· Excellent problem-solving, analytical, investigative and decision-making skills.

· Effective communication and interpersonal skills to mentor and train employees in conducting effective investigations into product/process failures, writing concise and thorough investigation reports into root causes, and evaluating potential preventative measures.

· The ability to manage multiple projects, priorities, and people in a fast-paced environment.

Education Experience and Other Requirements:

· A bachelor’s degree or higher.

· Five (5) or more years of experience as a paralegal or legal assistant.

· A demonstrated ability to interpret and understand complex legal and regulatory issues, directives, and guidance.

· A proven record of managing a variety of competing resource-intensive obligations.

· A strong tie to the Lenoir/Caldwell County community is a huge plus.