QA Scientist – Pharma GMP & Compliance

Kelly Services

Manatí (PR)

On-site

USD 75,000 - 110,000

Full time

14 days+
Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Medical
Dental
Vision
Telemedicine
Life insurance
Disability coverage
Retirement plan

Job summary

Kelly Science & Clinical is seeking a Quality Assurance Scientist to support the north region in Puerto Rico. The role requires strong pharmaceutical QA background with GMP/FDA/EU knowledge and the ability to interpret complex regulations.

The candidate should be proficient with TrackWise and SAP, and possess data analysis and root-cause investigation skills. Bilingual Spanish/English is required, and occasional irregular hours may be needed.

Qualifications

  • Bachelor degree in science with 6 years QA in pharma.
  • Knowledge of manufacturing operations for oral solid dosage and parenteral products.
  • Strong knowledge of GMP, FDA and EU regulations.
  • Proficient with TrackWise and SAP.
  • Data analysis and deviation investigation skills.
  • Root cause analysis methodologies (Kepner-Tregoe).
  • Fully bilingual Spanish/English written and verbal.
  • Willingness to work irregular hours and shifts.

Skills

GMP knowledge
FDA knowledge
Analytical skills
Root cause analysis
Bilingual (Spanish/English)

Education

Bachelor degree in Science with 6 years QA experience in pharma
PhD in Pharmacy with license in Puerto Rico

Tools

TrackWise
SAP

Job description

Kelly Science & Clinical is seeking a Quality Assurance Scientist to support the north region in Puerto Rico. The role requires strong pharmaceutical QA background with GMP/FDA/EU knowledge and the ability to interpret complex regulations.

The candidate should be proficient with TrackWise and SAP, and possess data analysis and root-cause investigation skills. Bilingual Spanish/English is required, and occasional irregular hours may be needed.

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Senior QA & Compliance Specialist (GMP/eBR)
Senior QA & Compliance Specialist (GMP/eBR)

Quality Consulting Group, LLC • Juncos (PR)

On-site
USD 70,000 - 95,000
Pharma Manufacturing & Quality Systems Specialist
Pharma Manufacturing & Quality Systems Specialist

FITS LLC • Juncos (PR)

On-site
USD 70,000 - 100,000
Change Control Specialist (Pharma) – Bilingual & QC Focus
Change Control Specialist (Pharma) – Bilingual & QC Focus

FITS LLC • Juncos (PR)

On-site
USD 70,000 - 95,000
Change Control & Manufacturing Specialist — Pharma QA
Change Control & Manufacturing Specialist — Pharma QA

FITS, LLC • Juncos (PR)

On-site
USD 65,000 - 90,000
Senior Quality Engineer: GMP Validation & Compliance Lead
Senior Quality Engineer: GMP Validation & Compliance Lead

Quality Consulting Group, LLC • Juncos (PR)

Hybrid
USD 90,000 - 130,000
QA Specialist: Validation & Regulatory Compliance
QA Specialist: Validation & Regulatory Compliance

QRC • Juncos (PR)

On-site
USD 65,000 - 90,000
Quality Specialist – Drug Substance | Process & Compliance
Quality Specialist – Drug Substance | Process & Compliance

FITS LLC • Juncos (PR)

Hybrid
USD 90,000 - 130,000
Quality Assurance Specialist: GMP, CAPA & NPI Leader
Quality Assurance Specialist: GMP, CAPA & NPI Leader

Quality Consulting Group, LLC • Juncos (PR)

On-site
USD 90,000 - 150,000
Pharma Change Control Specialist - Quality & Compliance
Pharma Change Control Specialist - Quality & Compliance

FITS, LLC • Juncos (PR)

On-site
USD 65,000 - 85,000
On-site QA Specialist: cGMP & NPI Quality Lead
On-site QA Specialist: cGMP & NPI Quality Lead

ProQuality Network • Juncos (PR)

On-site
USD 60,000 - 90,000