Product Release Technician

TITLE: Product Release Technician

SHIFT: Monday - Friday 8-hours (occasional weekends required)

BENEFITS:

• Medical Dental Vision Life Short-term/Long-term Disability Insurances effective 30 days after first full Month!
• 401(k) Match!
• 7 Paid Holidays & 3 Floating Holidays for use at employees discretion
• Immediately eligible for holiday and vacation pay!
• Annual allowance for prescription safety glasses
• Climate-controlled and cleanest work environment in Morristown!
• Education & Fitness reimbursement
• Employee Product Giveaways!
• Employee Referral Program $$$!
• Associate Discount Programs

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 and Solution Reconciliation for products produced by Iatric.
• Provide daily support to Quality System 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 companys 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.)

• Four years of experience in a manufacturing or quality role or an equivalent combination of education and experience is required. An Associates 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 FDAs 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

FLSA Status: Non-Exempt

Pay Grade: 06

Required Experience:

IC