Regulatory Affairs Specialist II

TechDigital Group; Dallas (TX); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is looking for an Associate Technician to join their dynamic Packaging team. In this role, you will be pivotal in loading, monitoring, and packaging diagnostic panels and reagent products. You will thrive in a collaborative, goal-oriented environment, ensuring adherence to quality standards and operational plans. This position offers a great opportunity to engage in lean manufacturing principles and contribute to continuous quality improvements. If you are detail-oriented and enjoy working in a regulated industry, this is an exciting chance to advance your career in a supportive team setting.

Qualifications

• High School Degree or Equivalent; experience in a regulated industry preferred.
• Basic analytical skills required for daily tasks.

Responsibilities

• Follow established work instructions and procedures with emphasis on quality.
• Execute daily production plans and maintain compliance with FDA and ISO standards.

Skills

Analytical Skills

Teamwork

Attention to Detail

Education

High School Degree or Equivalent

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Windows Operating System

Job description

Associate Technician Production Operations (O2)

Description/Comment: Our manufacturing company is seeking a team member to join our Packaging team. In this role you will load diagnostic panels, monitor the drying process, unload diagnostic panels, and package diagnostic panels and reagent products of varied complexity according to operational plans and customer demand. We're looking for associates who thrive in a team-oriented, goal-focused environment. We operate using Daily Management principles, providing immediate guidance and feedback to our associates and focusing on daily, monthly, and quarterly objectives.

You'll be responsible for following established operation procedures, maintaining appropriate training records for your role, sustaining a smooth flow of material and the execution of work orders to on-time completion.

KEY RESPONSIBILITIES:

1. Read and follow established work instructions and procedures with emphasis on quality.
2. Execute the daily production plan to due date conformance and quality standards.
3. Train to Standard Operating Procedures (SOPs).
4. Follow engineering drawings, work order information, SOPs, and other written and verbal specifications in the manufacturing process while maintaining FDA requirements.
5. Independently execute work regarding drying and packaging of panels.
6. Apply basic analytical skills or scientific methods to perform daily tasks.
7. Perform the set-up, testing and troubleshooting of diagnostic panels.
8. Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
9. Work directly and cooperatively with cross-functional team members to troubleshoot issues and ensure emphasis on quality.
10. Identify, recommend and implement quality improvements including but not limited to production methods, equipment performance, product quality, and efficiencies.
11. Learn and participate in the company's lean manufacturing principles.
12. Maintain a safe and clean working environment by complying with procedures, rules, and regulations.
13. Perform other duties and cross training as assigned.
14. Train new team members on equipment operations and work procedures as needed.
15. Ability to complete appropriate paperwork, maintain accurate records of production and report status of work.
16. Proficiency with Microsoft applications, including Word, PowerPoint, and Excel and the basic Windows operating system.

EDUCATION/EXPERIENCE:

High School Degree or Equivalent. Experience in a regulated industry preferred (e.g. FDA, ISO).