Manufacturing Compliance Specialist

Position Objective: Manufacturing Compliance Specialist

Are you ready to play a vital role in the heart of our operations? As an Manufacturing Compliance Specialist, you'll be at the forefront of driving process improvements, ensuring compliance, and supporting key business activities. You'll manage essential tasks like updating SOPs, executing NC and CAPAs, and overseeing OEM operations—all while working closely with cross-functional teams to ensure seamless execution. This is your opportunity to make a real impact in a highly regulated, dynamic environment where attention to detail and a passion for excellence are key.

Key Responsibilities:

• Collaborate and Innovate: Work with cross-functional teams to support validations and drive continuous improvements in our processes.


• Lead SOP Management: Take charge of SOP reviews and updates to ensure smooth operations and compliance.


• Problem Solve: Write and execute NC (Non-conformance) and CAPAs (Corrective and Preventive Actions) for operations, ensuring timely resolution of issues.


• Ensure Compliance: Maintain up-to-date training records and documentation to meet regulatory standards.


• Support OEM Operations: Oversee daily OEM activities across Processing, Assembly, and Final Pack, ensuring high-quality output.


• Drive Performance: Develop and track KPIs to measure success and implement corrective plans when needed.


• Maintain Inventory: Collaborate with Purchasing to manage consumables and keep inventory levels optimal.


• Audit for Excellence: Conduct regular audits, including Safety, 5S, Gemba, and eGMP, ensuring best practices are followed.


• Support Leadership: Run detailed reports and provide valuable insights to support management decision-making.


• Foster Learning: Assist in developing comprehensive training plans to elevate team performance.

Qualifications:

• Education: High school diploma or equivalent required; Associate’s degree preferred.


• Experience: 5+ years in an FDA-regulated or highly regulated environment is essential, with experience in FDA and ISO manufacturing practices being a plus.


• Tech-Savvy: Proficiency in Microsoft Office Suite and SAP inventory software.


• Skills: Strong verbal and written communication skills, with the ability to motivate teams and drive results.


• GMP Training: Understanding of GMP (Good Manufacturing Practices) is required.


• Organized: Exceptional organizational and prioritization skills to manage multiple tasks effectively.

Benefits

• Medical, Dental, and Vision Insurance


• 401(k) Retirement Plan


• Unlimited PTO


• Employee Stock Purchase Program