QA 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 Assurance Coordinator provides support to operations in meeting key performance metrics. Overall responsibilities include maintenance of the quality system documentation, in-process and final inspections, supplier quality assurance, 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:

· Conduct regular audits of the production areas.

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

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

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

· Ensure that customer requirements are well communicated among all CCT team members.

· Participate in the release or revision of standard operating procedures and work instructions when assigned.

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

· Evaluate the effectiveness of implemented corrective action plans in resolving the issue to the customer’s satisfaction.

· Assist customers on matters related to on-going investigations of complaints.

· Provide leadership in the continuous improvement of the plant’s quality management system.

· Ensure product specifications are available at points of use.

· Conduct first article inspections.

· Identify supplier quality non-conformances and issue supplier corrective action requests (SCAR).

· Manage Supplier performance through DMR

· Follow up with suppliers to ensure acceptable response to SCAR’s.

· Support supplier evaluations in accordance with documented procedures.

· Ensure all non-conforming product is properly labeled and dispositioned in accordance with documented procedures.

· Provide input to customer complaint investigations.

· Assist in training others on new procedures in response to changing customer requirements.

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

· Participate in customer and 3rd party audits.

· Assist, when needed, with in-process and final inspections.

· Prepare Certificates of Compliance (COC’s) to ensure quality of product prior to shipment.

· Work in compliance with all safety guidelines.

· Support the company’s 5S program.

· Other duties and responsibilities as assigned.

Qualifications and Requirements:

· Minimum of five years’ experience in quality assurance within an ISO registered

environment.

· Strong focus on the needs and expectations of external customers.

· ‘Good understanding of the documentation requirements for a quality management

system.

· Strong project management skills with a demonstrated record of results achieved.

· Associate degree; Bachelor’s preferred.

· Trained ISO 9001:2015 internal auditor, is a plus.

· Experience in a cGMP environment.

· Ability to accurately measure materials using standard metrology equipment.

· Some experience with the Six Sigma DMAIC methodology; Green Belt certified preferred.

· Ability to use Minitab software, preferred.

· Proficient with Microsoft Word, Excel, Access.

· Experience utilizing a manufacturing ERP software application.

· Strong interpersonal skills with an ability to collaborate with employees across

departments.

· Excellent verbal and written communication skills.

· Ability to quickly adapt to changing priorities and customer requirements.

Job Type: Full-time

Pay: $24.00 - $25.00 per hour

Expected hours: 40.0 per week

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 : $24 - $25