On-Site QA Specialist – PET Radiopharmaceuticals (Night Shift)

Automatic Data Processing, Inc.

San Juan (PR)

On-site

USD 90,000 - 115,000

Full time

3 days ago
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Benefits offered by this job

401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Extended health care
Life insurance
On-site parking
Paid time off
Vision care

Job summary

PharmaLogic is seeking an On-Site Quality Assurance Specialist in San Juan, PR. The role oversees PET drug quality control, materials acceptance, batch release, and CAPA within a cGMP framework. This position acts as the site expert on PET QA and prepares for FDA inspections.

The candidate will handle environmental monitoring, calibration, SOP maintenance, and training; ensuring QA tasks comply with regulatory standards and company SOPs across production and QC activities.

Qualifications

  • BS/BA degree in a relevant scientific discipline with 3–5 years of quality experience in pharma (or equivalent).
  • Strong analytical and critical thinking skills; customer service mindset.
  • Experience working with ionizing radiation and regulatory environments (cGMP, CFR).

Responsibilities

  • Ensure compliance with regulatory commitments and SOPs including cGMP and radiation safety.
  • Oversee production operations to ensure PET drugs meet identity, strength, quality and purity.
  • Review batch, laboratory and production records before batch release; approve or reject batches per SOPs; perform batch trending.

Skills

Analytical thinking
Critical thinking
Customer service
Cross-functional teamwork

Education

BS/BA in a relevant scientific discipline

Job description

PharmaLogic is seeking an On-Site Quality Assurance Specialist in San Juan, PR. The role oversees PET drug quality control, materials acceptance, batch release, and CAPA within a cGMP framework. This position acts as the site expert on PET QA and prepares for FDA inspections.

The candidate will handle environmental monitoring, calibration, SOP maintenance, and training; ensuring QA tasks comply with regulatory standards and company SOPs across production and QC activities.

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