Quality Assurance Coordinator

Job Title:

Quality Assurance Coordinator

About Us:

Cold Chain Technologies is a leading global provider of advanced thermal packaging assurance products, digital solutions and services for the transport of temperature-sensitive material, principally serving the pharmaceutical, biotech, diagnostics, health care and medical device industries. With more than 50 years of experience in ensuring product safety in transit, CCT has built a reputation as the industry's most innovative and reliable provider to the largest global life sciences companies and has had a history of vigorous growth. CCT today has the broadest portfolio of products, including the largest digitally enabled parcel shipper fleet in the industry. CCT also leads the industry in offering high performing, sustainable solutions, replacing fossil fuel-based materials.

The company’s headquarters is in Franklin, MA, and is ISO 9001: 2015 registered. CCT has additional facilities in Nashville, TN, Center Valley PA, Elgin, IL, Dallas TX, and San Diego, CA. CCT is also manufacturing and distributing products in Europe, Latin America and Asia, with significant growth coming through international expansion. CCT’s design and ISTA-certified testing laboratories are universally recognized throughout the industry as world-class.

Summary:

The Quality Coordinator reports functionally to the Global Director, Quality and in the region to the PA Site Leader. The Quality Assurance Coordinator provides support to operations in meeting key performance metrics. Serves as decision maker on the production floor. Overall responsibilities include maintenance of the quality system documentation, in-process and final inspections, supplier quality assurance, incoming material inspection, internal audits, trend analysis reporting, and special projects. The position requires knowledge of commonly used concepts, practices and procedures within the field and relies on a certain degree of experience and judgment to plan and accomplish tasks.

Primary Responsibilities:

· Carry out quality audits of the production areas as required to ensure procedural compliance and continuously improve quality performance.

· Support 3rd party and customer audits for the CCT site.

· Perform incoming inspections to ensure defect-free material flow.

· Prepare Certificates of Compliance (COCs)

· Conduct internal audits of the quality management system when assigned.

· Prepare trend charts for key quality metrics and assist in responding to negative trends.

· Conduct First Article Inspections

· Interface with external customers and suppliers on quality-related issues.

· Identify supplier quality non-conformances, issue, and track Supplier Corrective Action Requests (SCARs).

· Manage supplier performance through DMR.

· Provide input to customer complaint investigations.

· Support problem solving and continuous improvement projects utilizing Lean/Six Sigma tools and methodologies.

· Evaluate the effectiveness of implemented corrective action plans.

· Ensure full compliance with all documentation related to the quality management system and define opportunities to simplify and standardize across multiple sites.

· Actively support EH&S Rules and regulations.

· Maintain OSHA required documentation

· Maintain SDS library and hazard communication

· Document and assist with investigations of safety events

· Coordinate OSHA required safety training

· Manage hazardous waste disposal

· Other duties and responsibilities as assigned

Qualifications and Requirements:

· Associate degree with at least 5 years of experience in a manufacturing environment.

· Working knowledge of Quality Management System standards (i.e., ISO 9001:2015, AS9100, IATF 16949).

· Must be fluent in English

· Experience in a cGMP environment

· Ability to accurately measure materials using standard metrology equipment.

· Problem solving experience

· Proficient with Microsoft Word, Excel, Access

· Experience working with a manufacturing ERP SW application.

· Proven experience working remote from corporate function.

· Skilled problem solver, specifically related to customer and 3rd party audit findings.

· Ability to quicky adapt to changing priorities and customer requirements

· Ability to multitask and work with associates at all levels of the organization (up, down and across the organization).

· Excellent verbal and written communication skills

· Ability to be physically active (lifting, standing, bending, reaching, etc.) and ability to lift 23 KG occasionally and less weight frequently.

PREFERRED QUALIFICATIONS:

· Bachelor’s degree with at least 3 years of experience in quality assurance.

· Proven Quality System auditing experience

· Six Sigma Green Belt

· Experience with Quality Management System Software (MasterControl)

· Proven experience working directly with customers.

· Proven experience working directly with suppliers.

· Advance knowledge and skills using Microsoft Office suite (Word, Excel, Access, PowerPoint)

· EHS Experience

Job Type: Full-time

Pay: $25.00 - $26.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience:

• Quality Assurance: 3 years (Required)
• Product Audit: 3 years (Required)
• ISO 9001: 3 years (Preferred)
• Lean manufacturing: 3 years (Required)
• Working in a Manufacturing Environment: 2 years (Required)

Ability to Commute:

• Bethlehem, PA 18020 (Required)

Work Location: In person

Salary : $25 - $26