Rockline Industries & Iatric Manufacturing
QA Systems Coordinator
Rockline Industries & Iatric Manufacturing, Morristown, Tennessee, us, 37815
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 and Annual Quality Management Review Metrics, reviewing batch record/DHR packets and performing final release of finished goods as needed, 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 maintainingdeviations. Assist in the CAPA process.•Participate in creating yearly internal audit schedule. Perform Internal Audits in accordance with schedule andhelp ensure effective implementation and review of Quality procedures through the Iatric Internal Audit Systemin conformance with Regulatory, Customer, and Iatric standards.•Perform review of DHR packets and perform final release of finished product as needed.•Coordinate and prepare 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 duebiennial reviews with input from team members.•Identify 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. Assumetasks 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 andprocedures to ensure a thorough understanding and effective implementation of quality policies andprocedures.•Demonstrate commitment to Rockline/Iatric's RRITE Values of Renew, Respect, Integrity, Teamwork, andExcellence.•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 associate's essential accountabilities.•Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, asneeded or requested
QUALIFICATION REQUIREMENTS:
(To perform this job successfully, an individual must be able to perform each of theessential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/orability required.)
Bachelor's degree in Quality, Operations or related field and one year of Quality Assurance/Systems experience for FDAregulated products (For example: cosmetics, OTC Drug, Medical Device) or equivalent combination of education andexperience. Experience with Electronic Document / Quality systems, such as Docushare, Agile preferred. Experiencewith Quality Assurance & Quality Control fields primarily in manufacturing environments and experience with QualitySystems and regulatory requirements (21CFR 210, 211, 820) desired. Must have good organization and planning skillsalong with ability to manage multiple priorities. Knowledge of Non-Conformance process, document control, changeand process control preferred.
PHYSICAL AND MENTAL REQUIREMENTS : (The physical demands described here are representatives of those that mustbe met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may bemade 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 andreaching.•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.
OfficeProduction Floor
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
ESSENTIAL ACCOUNTABILITIES :•Coordinate, assist in and complete Nonconformance investigations, audit work orders, and maintainingdeviations. Assist in the CAPA process.•Participate in creating yearly internal audit schedule. Perform Internal Audits in accordance with schedule andhelp ensure effective implementation and review of Quality procedures through the Iatric Internal Audit Systemin conformance with Regulatory, Customer, and Iatric standards.•Perform review of DHR packets and perform final release of finished product as needed.•Coordinate and prepare 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 duebiennial reviews with input from team members.•Identify 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. Assumetasks 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 andprocedures to ensure a thorough understanding and effective implementation of quality policies andprocedures.•Demonstrate commitment to Rockline/Iatric's RRITE Values of Renew, Respect, Integrity, Teamwork, andExcellence.•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 associate's essential accountabilities.•Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, asneeded or requested
QUALIFICATION REQUIREMENTS:
(To perform this job successfully, an individual must be able to perform each of theessential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/orability required.)
Bachelor's degree in Quality, Operations or related field and one year of Quality Assurance/Systems experience for FDAregulated products (For example: cosmetics, OTC Drug, Medical Device) or equivalent combination of education andexperience. Experience with Electronic Document / Quality systems, such as Docushare, Agile preferred. Experiencewith Quality Assurance & Quality Control fields primarily in manufacturing environments and experience with QualitySystems and regulatory requirements (21CFR 210, 211, 820) desired. Must have good organization and planning skillsalong with ability to manage multiple priorities. Knowledge of Non-Conformance process, document control, changeand process control preferred.
PHYSICAL AND MENTAL REQUIREMENTS : (The physical demands described here are representatives of those that mustbe met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may bemade 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 andreaching.•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.
OfficeProduction Floor
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)