JQ908
Located in Texarkana, TX
Pay: $16-18.50
Job Full Description
Position: Quality Systems Coordinator
Location: Texarkana, TX
Pay: $16-18.50
Hours: M-Th. 7am - 4:30pm & Fri. 7am - 12pm
MUST HAVE EXPERIENCE IN QUALITY SYSTEMS
PURPOSE:
The Quality Systems Coordinator is responsible for report preparation and writing in relation to deviations to conform with the Code of Federal Regulations regarding interdepartmental projects. As part of this position they will also be responsible for facilitating internal deviation and investigation reports. This will include performing investigations, interviewing personnel, determining Root Causes, suggesting Corrective and Preventative Actions (CAPAs), and develop plans for the execution of CAPAs in collaboration with area managers, and under the guidance of the Quality Systems Supervisor. The Coordinator will also assist in the execution of programs including Stability, Annual Product Reviews, the Complaint Program, Documentation, SOPs, CAPA management, Deviations, and handling of Out of Specification (OOS) results.
EDUCATION REQUIRED:
- 4-year college degree or equivalent is preferred but not required.
- Experience with writing technical documents.
- Strong written and verbal communication and experience working with content across multiple mediums.
- Excellent attention to detail with the ability to prioritize and work on multiple projects in a fast-paced, changing environment.
- The ability to work independently and cross-departmentally to perform internal investigations and gather research.
JOB FUNCTIONS:
- Stability Program Support: Assist in the monitoring of stability studies to ensure product compliance and shelf life.
- Annual Product Reviews Support: Help compile annual product reviews to assess quality standards and promote continuous improvement.
- Complaint Program Assistance: Support the management of the customer complaint program to ensure comprehensive investigation and resolution.
- Documentation Support: Help manage the documentation system for maintaining regulatory compliance.
- SOP Assistance: Support the maintenance and implementation of SOPs to ensure consistent operations.
- Training Program Assistance: Help implement training programs for employees on quality protocols.
- Audit and Inspection Preparation: Assist in preparing for and supporting internal and external audits and inspections.
- Continuous Improvement Initiatives: Support the identification and implementation of continuous improvement in quality systems and processes.
- CAPA Support: Assist in managing corrective and preventive actions to address quality issues.
- Deviation Management Support: Help oversee the resolution of deviations from SOPs to ensure quality and compliance.
- Customer Communication Support: Maintain support communication with customers and external quality systems.
- Documentation and Data Management Support: Assist in data analysis related to documentation deadlines and ensure training on updated SOPs.
- Product Review and Compliance Assistance: Support the monitoring of product stability data and the compilation of related quality and manufacturing process data.
- Quality Collaboration: Assist with collaboration between the QC Lab, Packaging & Labeling, and other departments for sample collection and testing.
- Incident and Deviation Oversight Assistance: Support incident and deviation investigations and ensure compliance with regulatory standards.
- Process Optimization Support: Assist in identifying and implementing process improvements and optimizations.
- Communication and Coordination: Support the development of project timelines and maintain open communication across departments.
- General Responsibilities: Assist in planning and executing program changes and perform all other duties as assigned.
PERFORMANCE STANDARDS:
This job must be performed with a low level of supervision, and/or direction from the Stability & APR Supervisor in a way which will ensure a safe and quality finished good product in conjunction with complete compliance with Pharma Nobis cGMP process. Good job performance will include the initiative to do work and solve routine problems before being so directed, and to consult with management or other applicable resources as necessary.
The position may require evening and/or weekend work on short notice.
Duties must always be conducted in a professional manner, and all personnel must be treated with courtesy and respect. A positive attitude with a willingness to embrace new challenges is key. Punctuality and attendance is required subject to Pharma Nobis Attendance & Tardy policies, in conjunction with corrective counseling (up to and including termination).
PHYSICAL DEMANDS:
This position requires sitting, standing, walking, reaching, stooping, and the use of both hands along with lifting up to 40 pounds while bending and twisting of the upper body. Specific vision abilities include the use of continual reading from a computer monitor for long periods of time.
ENVIRONMENTAL DEMANDS:
This position requires working for long extended periods of time with a computer screen and keyboard. Occasionally, the job involves working around elevated noise levels. These levels are not damaging but can be uncomfortable at times. As a result, Pharma Nobis does make earplugs available for use by all employees. The job may also involve working around machinery with exposed moving parts, which can pose a mechanical hazard if proper operating procedures are not followed. Also, in a typical workday, the job may involve working around forms of dust and chemical hazards. If a project requires actual contact with any product, Safety Data Sheet information provides instruction about the personal protective equipment (PPE) that must be worn.
BEHAVIORAL SKILLS:
Ability to make decisions and set priorities to include recognizing important elements of the job, estimating time needed to perform tasks, and drawing conclusions about problems/situations based on provided facts as needed to identify problems and recommend actions for solutions, schedule work for self and others, work without direct supervision, and respond to emergency situations.
Ability to interact with supervisors, co-workers, and the public while remaining calm and courteous. Being open to and sharing ideas as needed when conducting investigations, handling complaints or performing investigations in other rare, ambiguous situations while abiding by policies and procedures and maintaining good company relations is necessary.
Texarkana, AR
1125
4323 Jefferson Avenue
Texarkana, AR 71854
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