Title: Quality Operations Specialist I

Duration: 6 Months

Location: Fort Worth, TX 76134

Pay Rate: $21.32/Hr

Major Accountabilities:

Perform activities that ensure required quality and safety standards are being met for our products.

Management of customer complaints including documentation, logging on through iTrack, investigation and root cause analysis, associated corrective actions and preventative actions (CAPA) activities, tracking, trending and reporting.

Implementation of local quality systems that comply with standards and regulatory requirements.

Assure GMP requirements/compliance are adhered.

Escalate quality issues.

Excellent technical writing skills.

A thorough understanding of all aspects of the manufacturing facility, process, procedures, and equipment is required.

Ensure operational, review timelines, projects, and assigned tasks are completed on time and per procedural guidelines.

Perform visual inspection of returned complaint samples and retained samples, proper distribution, and archival of incoming

customer complaint samples and Internal Complaint samples from multiple countries/jurisdictions around the world.

Collaborate with production teams to review/evaluate returned complaint samples and help determine root cause and

appropriate corrective actions.

Independently carry out work as required to meet defined deadlines and operational KPI goals.

Organize work and effectively execute time management.

Participate in problem solving and troubleshooting of issues.

Work cohesively with and support collaboration and training needs of team members.

Work with cross functional teams to analyze data and create solutions.

Communicate effectively with production, laboratories, maintenance, warehouse, and other functions as necessary.

Communicate trends and potential issues to upper management and internal departments.

Pull and inspect samples to the appropriate QA laboratory for testing as needed for investigations.

Experience:

Bachelor's Degree or Equivalent years of directly related experience (or high school 8 yrs; Assoc. 4 yrs)