Senior Quality Assurance Auditor

Kelly Science, Engineering, Technology & Telecom; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Bi-Weekly pay by W-2

Christmas bonus

Job summary

Kelly Science is seeking a Senior QA Auditor in Juncos, PR to lead quality assurance activities in a biotech manufacturing setting. The role requires oversight of GMP compliance, quality systems, and validation life cycle, with responsibility for audits, investigations, and CAPAs.

You will collaborate with cross-functional teams, review validation protocols and reports, support process improvements, and ensure data integrity across manufacturing operations.

Qualifications

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years in QA/validation/manufacturing.
• Strong knowledge of GMP, Data Integrity, Quality Systems, Change Control, Risk Management and validation lifecycle.
• Experience auditing and supporting manufacturing processes, validation, equipment qualification, facilities/utilities commissioning and CSV.
• Demonstrated ability to lead audit investigations and drive CAPAs.
• Experience with KNEAT, CDOCS, SCADA, TrackWise, Maximo or similar platforms.
• Excellent written and verbal communication in English and Spanish.

Responsibilities

• Lead QA audits and investigate compliance issues.
• Review manufacturing processes and validation activities.
• Approve quality systems, CAPA and change controls.
• Provide data analysis and interpretation for projects.
• Collaborate with cross‑functional teams to ensure GMP compliance.

Skills

QA auditing

GMP compliance

Data integrity

Documentation

Risk assessment

CAPA leadership

Biotech manufacturing

English & Spanish

Education

Bachelor’s in Life Science or Engineering

Master’s in Life Science or Engineering

Doctorate in Life Science or Engineering

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

At Kelly® Science, we’re passionate about helping you find a job that works for you.

We’re seeking Senior QA Auditor to work for one of our top biotechnology industry clients at Juncos, PR.

Shift: 8hrs shift | Administrative - with work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Why you should apply to be Senior QA Auditor:

• Competitive pay rate and opportunity for professional growth
• Work with a leading organization in the manufacturing sector
• Contribute to a culture of safety, innovation, and operational excellence
• Bi-Weekly pay by W-2
• Christmas bonus*

*Must comply with minimum established requirements to qualify.

This job might be an outstanding fit if you have the following qualifications:

• Doctorate with 2+ years, Master’s with 4+ years, or Bachelor’s with 6+ years of directly related Quality Assurance, Validation, or Manufacturing experience. (Degrees in Life Science or Engineering)
• Strong knowledge of GMP regulations, Good Documentation Practices, Data Integrity, Quality Systems, Change Control, Risk Management, and validation lifecycle activities.
• Experience auditing and supporting manufacturing processes, process validation, equipment qualification, facilities/utilities commissioning and qualification, and Computer System Validation (CSV).
• Demonstrated ability to lead audit investigations, assess compliance issues, perform risk assessments, and drive effective corrective and preventive actions (CAPAs).
• Experience working with quality and manufacturing systems including KNEAT, CDOCS, SCADA, TrackWise, Maximo, or similar platforms.
• Strong technical documentation, written and verbal communication skills (English & Spanish)

The Senior QA Auditor serves as the Quality Assurance technical lead, providing oversight and approval of manufacturing processes, validation activities, investigations, and quality systems. Partner with cross-functional teams to ensure GMP compliance, support new product introductions, manage quality risks, and drive continuous improvement across manufacturing operations. Designs, monitors or conduct experimental strategies. Provides data analysis and interpretation and assesses impact of the data on the project. Review and approve manufacturing processes, validation protocols and reports, environmental characterization reports, planned incidents, and sanitary utility system releases while ensuring compliance with GMP requirements. Lead quality audit investigations, represent QA on cross-functional teams and governance boards, support new product introductions, and maintain site quality programs and procedures.

Helping you discover what’s next in your career is what we’re all about, so let’s get to work.