Product Release Technician

Rockline Industries • Morristown, TN

125d

About The Position

The Product Release Technician is responsible for ensuring that DHR documents are submitted in a timely manner, are complete and accurate, and that products are released according to the determined schedule. This role involves managing the check out/check in process of DHR packets, preparing Certificates of Analysis or Certificates of Manufacture, and providing daily support to the Quality System Manager and QA Manager regarding product quality and release issues. The technician will also work on special projects as assigned, review product specifications, assist with data collection for FDA matrices, and participate in annual internal audits. A commitment to the company's values of Renew, Respect, Integrity, Teamwork, and Excellence is essential, as is the ability to perform work safely and cooperatively.

Requirements

• Four years of experience in a manufacturing or quality role, or an equivalent combination of education and experience.
• An Associate's degree in a technical field (biology, chemistry, engineering) preferred.
• High degree of attention to detail.
• Experience working in an FDA regulated environment strongly preferred.
• Working knowledge of Microsoft tools - Word, Excel, Power Point, and Outlook.
• Good problem-solving and communication skills.
• Working knowledge of the FDA's regulations from '21 CFR' preferred.
• Ability to work in a fast-paced high-pressure environment with limited supervision.
• 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.

Responsibilities

• Ensure DHR documents are submitted in a timely manner, are complete and accurate, and that product is released per determined schedule.
• Manage check out/check in process of DHR packets and confirm audit readiness.
• Prepare Certificates of Analysis or Certificates of Manufacture and Solution Reconciliation for products.
• Provide daily support to Quality System Manager and QA Manager regarding product quality/release issues.
• Work on special projects as assigned by the QA Systems Manager or QA Manager.
• Review product specifications for new products and updates to existing specifications.
• Assist with data collection for Quarterly and Annual FDA matrices and annual product reviews.
• Participate in annual internal audits.
• Demonstrate commitment to the company's RRITE Values.
• Contribute to a cooperative working effort by performing other job-related work as needed.

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 employee's 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.

What This Job Offers

• Job Type: Full-time
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Associate degree