ESSENTIAL ACCOUNTABILITIES:

• Ensure DHR documents are submitted in a timely manner, are complete and accurate, have no open Nonconformances, and product is released per determined schedule. Ensure DHR packets are stored in appropriate manner and manage check out/check in process and confirm audit readiness of DHR packets/process.
• Preparing Certificates of Analysis or Certificates of Manufacture for products produced by Iatric.
• Provide daily support to Quality Support Manager and QA Manager relative to product quality/release related issues.
• Work on special projects as assigned by the QA Systems Manager or QA Manager.
• Review product specifications for new products, updates to existing specifications, align specifications with Rockline Controlled Documents (Procedures, Work Instructions, Test Methods, Forms, etc.).
• Assist with data collection for Quarterly and Annual FDA matrices and annual product reviews along with recording this data in PBL format.
• Participate in annual internal audits.
• Demonstrate commitment to the company's 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 associate's 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.)

• Four years of experience in a manufacturing or quality role, or an equivalent combination of education and experience is required. An Associate's degree in technical field (biology, chemistry, engineering) preferred.
• A high degree of attention to detail is a must in this position.
• Experience working in a FDA regulated environment strongly preferred.
• Working knowledge of Microsoft tools - Word, Excel, Power Point and Outlook - is a must.
• Good problem-solving and communication skills are a must.
• Working knowledge of the FDA's regulations from "21 CFR" is preferred.
• The ability to work in a fast pace high pressure environment with limited supervision is a plus.
• General understanding of manufacturing batch records/DHRs in a regulated manufacturing environment.
• Experience in interpreting and applying product specifications strongly desired.
• Prior experience in creating excel tracking sheets and inputting data into excel.

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)

• Constant sitting; occasional standing/walking
• Occasional carrying and lifting 0-10 pounds, repetitive hand movement, reading, writing, reasoning/analyzing, and social interaction

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.)

• Inside, office environment

Pay Grade: 06