Quality Systems Coordinator

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TITLE: Quality Systems Coordinator

SHIFT: Monday - Friday 8-hour shift (onsite position)

LOCATION: Morristown TN (This position is based in Morristown TN and requires local residency. Visa sponsorship and relocation assistance are not available)

COMPENSATION & BENEFITS:

• Medical dental vision prescription drug coverage life insurance short-term/long-term disability (effective the 1st of the months following 30 days of continued service)
• 401k w/ company match
• 7 paid holidays and 3 floating holidays for use at associates discretion
• Immediately eligible for vacation and holiday pay!
• Annual allowance for prescription safety glasses
• Education and fitness reimbursement
• Associate referral program $$$!
• Associate discount programs
• Overtime available

POSITION SUMMARY:

This position maintains documents metrics and processes that are ready for external and internal audits at all times by helping to create and maintain Quality processes assisting in Annual Product Review (APR) process managing and generating Quarterly and Annual Quality Management Review Metrics reviewing batch record/DHR packets and performing final release of finished goods perform internal audits perform mock recalls generate FDA Quarterly metrics perform root cause analysis investigations (as needed) generate Customer CofA/CofM and support external customer and regulatory audits.

ESSENTIAL ACCOUNTABILITIES:

• Coordinate assist in and complete Nonconformance investigations audit work orders and maintaining deviations. Assist in the CAPA process.
• Participate in creating yearly internal audit schedule. Perform Internal Audits in accordance with schedule and help ensure effective implementation and review of Quality procedures through the Iatric Internal Audit System in conformance with Regulatory Customer and Iatric standards.
• Perform review of DHR packets and perform final release of finished product.
• Coordinate and prepare Quarterly and Annual Quality Management Review for Global Presentation.
• Assist in preparing Annual Product Review (APR) in accordance with customer and regulatory requirements. Organize and prepare data for Quarterly Quality Metrics to the FDA in accordance to guidance.
• Provide guidance to Document Coordinator to process Procedures and Work Instructions ensure no past due biennial reviews with input from team members.
• Identify lead or manage quality system document improvements. Improvements to focus on effectiveness efficiency and when applicable drive simplification.
• Perform Mock Recalls as required.
• Support Rockline QMS initiatives as one of the site representatives for Docushare Agile other systems. Assume tasks as needed to support Global and Site Quality Initiatives as determined by the Quality Management Team
• Provide quality expertise and guidance and working directly with Iatric Associates on quality system policies and procedures to ensure a thorough understanding and effective implementation of quality policies and procedures.
• Work with the Global Documents Group to establish and standardize global and site documents.
• Demonstrate commitment to Rockline/Iatrics RRITE Values of Renew Respect Integrity Teamwork and Excellence.
• Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associates essential accountabilities.
• Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work as needed or requested

QUALIFICATION REQUIREMENTS: (To perform this job successfully an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.)

• Bachelors degree in Quality Operations or related field and one year of Quality Assurance/Systems experience for FDA regulated products (For example: cosmetics OTC Drug Medical Device) or equivalent combination of education and experience.
• Experience with Electronic Document / Quality systems such as Docushare. Agile preferred.
• Experience with Quality Assurance & Quality Control fields primarily in manufacturing environments and experience with Quality Systems and regulatory requirements (21CFR) desired.
• Must have good organization and planning skills along with ability to manage multiple priorities.
• Knowledge of Non-Conformance process document control change and process control preferred.

PHYSICAL AND MENTAL REQUIREMENTS: (The physical demands described here are representatives of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions)

• Must be able to communicate face-to-face and over the phone
• Occasional lifting up to 35 lbs.
• Frequent standing/walking. Occasional sitting bending twisting kneeling climbing pushing/pulling and reaching.
• Repetitive hand and foot movement.
• Work environment includes occasional noise >85db hot and cold temperatures.
• Requires ability to read write calculate and analyze.
• Requires good visual acuity with depth perception and color vision.

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.)

• Office
• Production Floor

FLSA Status: Exempt

Grade: 09

Required Experience:

IC