Sign upLog in

QA Specialist / Deviation Investigator

QRC Group

Carolina, Puerto Rico

Apply
JOB DETAILS
SKILLS
Corrective and Preventative Action (CAPA) Systems, Data Analysis, Data Collection, GMP (Good Manufacturing Practices), Interviewing Skills, Investigative Reports, Manufacturing, Problem Solving Skills, Quality Assurance, Root Cause Analysis, Structured Analysis, Technical Writing
LOCATION
Carolina, Puerto Rico
POSTED
6 days ago
QA Specialist / Deviation Investigator<\/b> to lead investigations of deviations, non conformances, and quality events within a regulated manufacturing environment.
<\/div>
Key Responsibilities:<\/b>
<\/div>
  • Lead end‑to‑end investigations for deviations and quality events.
    <\/span><\/li>
  • Collect and analyze data, conduct interviews, and review technical documentation.
    <\/span><\/li>
  • Apply structured Root Cause Analysis tools (5 Whys, Fishbone, Fault Tree, etc.).
    <\/span><\/li>
  • Develop and manage effective CAPAs addressing true root causes.
    <\/span><\/li>
  • Prepare clear, compliant investigation reports aligned with GMP/GDP requirements.
    <\/span><\/li>
  • Collaborate with Operations, QA, Engineering, and other cross‑functional teams.
    <\/span><\/li>
  • Facilitate and lead problem‑solving and investigation meetings.
    <\/span><\/li><\/ul>

    <\/div><\/span>

    Requirements<\/h3>
    • Minimum 3–5 years of experience in deviation investigations<\/b>, QA operations, or quality systems in regulated environments.
      <\/span><\/li>
    • Experience with GMP/GDP environments and documentation.
      <\/span><\/li>
    • Proficiency with CAPA methodologies<\/b> and root‑cause‑analysis<\/b> tools.
      <\/span><\/li><\/ul>

      <\/div><\/span>

About the Company

Q

QRC Group

Resume Resources

Free Resume TemplatesFree Resume Builder