JobCubby JobCubby
Sign up
QRC Group

Sr Specialist QA

QRC Group Juncos, Puerto Rico, United States

Staffing and Recruiting · 51-200 employees

20 h ago
qa Senior (5-10 yrs) Contractor United States
Create a free account to apply — email only, no card. You can also save this posting or score it against your profile with AI.

About the role

The Senior Specialist QA acts as a technical specialist supporting the Quality Assurance program by reviewing and approving process validation protocols and reports. They also lead investigations, represent Quality on incident triage and NPI teams, and manage site quality program procedures.

What they look for

Quality Assurance Process Validation Incident Triage Environmental Characterization Facilities And Utilities Commissioning Computer System Validation Equipment Validation Risk Assessments Kneat Cdocs Scada Trackwise Maximo Good Documentation Practices Data Integrity Change Controls

Requirements

Candidates must possess a minimum of 6 years of directly related experience with a Bachelor's degree, or equivalent combinations of education and experience. Proficiency in facilities and utilities commissioning, validation processes, and quality management systems like TrackWise and Maximo is required.

Full description

We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs.

FUNCTIONS

- Approve process validation protocols and reports for mfg. processes.

- Represent Quality on incident triage team.

- Approve Environmental Characterization reports.

- Release of sanitary utility systems.

- Approve planned incidents.

- Represent QA on NPI team.

- Lead investigations.

- Own site quality program procedures.

Requirements

Education: Doctorate + 2 years of directly related experience or Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or High school/GED + 12 years of directly related experience.

Experience with:

  • Facilities and Utilities Commissioning and Qualification
  • Computer System Validation
  • Equipment validation
  • Risk Assessments
  • KNEAT,CDOCS, SCADA, TRACKWISE,MAXIMO
  • Good Documentation Practices, Data Integrity
  • Change Controls
  • Standard Operation Procedure
  • Syringe/Vials Inspection Process
  • Documents revision and approval
  • Strong knowledge of Decision Making Techniques
  • Risk Management

Similar roles