Quality Specialist

TEAM is seeking a Quality Specialist to work with our group in Morristown, TN.

Your main objectives are to assist the Quality Manager or Quality Director with daily QA/QC activities. Know and understand FDA regulatory requirements pertaining to site products. Maintain comprehensive and effective quality and regulatory programs designed and implemented that complies with FDA regulations, ISO requirements, Corporate Regulatory Compliance and other regulatory bodies. Train and support Team with complaint investigations and customer responses. Interact with auditors during customer and/or FDA audits. Lead and assess skills of quality inspectors.

ONE TEAM. MANY OPPORTUNITIES.

About Us

One TEAM. Many Technologies. TEAM is a rapidly growing end-to-end manufacturing solutions provider for our customers. With over 30 years of experience and technology, TEAM provides seamless, turnkey processes proven to positively impact customer’s business.

Founded in 1988 by three entrepreneurs in Morristown, Tennessee, TEAM began with a single guiding principle: TEAM will grow by partnering with our customers to drive their growth. In the spirit of our founders’ guiding principles, we continue to grow by adding new technologies to broaden our capabilities and provide solutions for our customer partners. As ONE TEAM with MANY TECHNOLOGIES, we stand ready to be “YOUR PARTNER FOR WHAT’S NEXT”. You can find TEAM in fourteen locations across the United States and three international locations.

How will you contribute to the team?

  • Inspects materials, in-process and finished product
  • Coordinate daily activities of other quality personnel
  • Manage quality logs, records, charts, specifications, KPI’s, etc…
  • Assists with validations as required
  • Manage annual document reviews
  • Performs internal audits
  • Train personnel on various topics
  • Assist with Root Cause Analysis and CAPA’s
  • Participates in continuous improvement activities
  • Perform non-conforming product investigations and disposition of materials
  • Maintain and perform trend analysis of the quality logs and issue numbers for CARs, SCARs, CAPA’s, Alerts, Controlled Document numbers, Visual Aids and others as implemented
  • Review, Control, Implement, Communicate, Archive and Audit procedures, forms, specifications, additions or changes involved with the quality system including external documents
  • Maintain Quality records both electronically and in hard copy, as required and applicable
  • Review, filing and preparing for retention records
  • Coordinates calibration activities
  • Be familiar and maintain working knowledge of FDA regulations, ISO, State, Foreign country requirements and other regulatory bodies of standard and ongoing changes to those that apply to quality systems
  • Perform other duties as assigned by the Quality Manager or Director
  • Other duties as assigned

What will you contribute?

  • High School diploma or equivalent
  • Proficiency with Microsoft Office including Excel, Word, Outlook, and PowerPoint
  • Must be able to read, understand, and communicate FDA requirements and guidelines
  • Must demonstrate integrity, confidentiality, and professionalism
  • Demonstrated ability to work independently with limited direction

What We Offer At TEAM

At TEAM, your benefits package includes:

  • Opportunity to work on various projects of various sizes
  • Paid Time Off (PTO)
  • Group Insurance; Medical, Dental, and Vision
  • Company paid Basic Life Insurance
  • Company paid Long-Term Disability Insurance
  • Access to other voluntary benefits such as life Insurance for you and your family and short-term disability insurance
  • 401(k) Savings Plan with employer match
  • Employee Assistance Program (EAP)
  • Company training programs
  • Career opportunities across the United States

To expand your career with us, apply today!

TEAM is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.