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QRC Group

Specialist QA

QRC Group Juncos, Puerto Rico, United States

Staffing and Recruiting · 51-200 employees

4 d ago
qa Mid (2-5 yrs) Contractor United States
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About the role

The Specialist QA is responsible for the review and approval of GMP documentation including change controls, deviations, CAPAs, protocols, and reports. They will also support packaging and inspection operations while collaborating with manufacturing, engineering, and process development teams.

What they look for

Quality Assurance GMP Change Control Deviations CAPA Protocols SOPs Packaging Operations Inspection Operations GDP Electronic Quality Systems Manufacturing Engineering Process Development Bilingual Communication

Requirements

Candidates must have a degree in a related field with applicable experience ranging from a high school diploma with 10 years of experience to a doctorate. Proficiency in GMP, GDP, electronic quality systems, and bilingual English/Spanish communication skills are required.

Full description

We are seeking a Specialist QA with GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired.

Requirements

  • Degree in a related field with applicable experience:
  • Doctorate, Master's + 2 years of experience, Bachelor's + 4 years of experience, Associate's + 8 years of experience, High School Diploma/GED + 10 years of experience.
  • Bilingual English and Spanish communication skills.
  • Experience in Quality Assurance within a GMP-regulated environment.
  • Experience reviewing and approving Change Controls, Deviations, CAPAs, Protocols, Reports, and SOPs.
  • Experience supporting packaging and inspection operations.

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