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Job Title:

Quality Systems Coordinator 1

Department/Group:

Quality

Location:

Assembly

Reports to:

Supervisor, Quality Systems

FLSA Status:

Non-Exempt

Prepared By:

Radmila Vazic

Date:

7/1/2022

Approved By:

Krista Anderson

7/1/2022

Summary of Objective:

The Quality Systems Coordinator is responsible for maintaining the activities relating to Change Control System, Corrective and Preventative Action System, Procedure Document Management as well as the Quality System Metrics. Have a working knowledge of the Change Control System, Corrective and Preventative Action (CAPA) System, and Procedure Document Management and Control Process.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Responsible for retrieval, filing and destruction of executed batch documentation and receiving reports. Responsible for assisting in the maintenance and collection of checked out executed batch documentation and receiving reports. Responsible for the entry of Quality System documentation into Electronic Quality Management System (eQMS). Responsible for the data entry management of documentation pertaining to the Change Control Process. Responsible for the data entry management of documentation pertaining to the CAPA process. Cross-train in other Quality System positions, as assigned. Knowledge on how to properly assess proof of closure for Change Control and CAPA actions. Complete metrics as assigned for Change Controls, Work Practices, SOP's and CAPA's and report these numbers in a timely manner. Responsible for processing of Standard Operating Procedures, Work Instructions, Job Aids and Forms through Electronic Document Management System Master Control. Responsible for the maintaining oversight of all PCI Logbooks, including the development, ordering, issuance and retirement of the logbooks. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: None
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
• Communicate or exchange information: From 1/2 to 3/4 of the day.
• Detect, distinguish, or determine: From 1/2 to 3/4 of the day.

On an average day, the individual can expect to move and/or transport up to 25 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
• Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment for 1/2 to 3/4 of the day.

The noise level in the work environment is typically, very quiet.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 1-3 years related experience and/or training.

• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred

• Ability to demonstrate attention to detail.
• Ability to work independently and/or part of a team.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.

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