Quality Systems Specialist II - Process Improvement

PCI Pharma Services; San Diego (CA); On-site; USD 76,000 - 86,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Bonus eligibility

Job summary

PCI Pharma Services in San Diego, CA seeks a Quality Systems Specialist II to advance increasingly complex QA/QMS activities and ensure records are complete, compliant, and inspection-ready. You will support deviations, investigations, CAPAs, and change controls, coordinating with cross-functional teams to push records forward with limited supervision.

The role requires strong analytical and communication skills, with exposure to GMP and international regulatory expectations.

Qualifications

• Experience in QA/QMS, pharma manufacturing or biotech is required.
• Familiarity with GMP and international regulatory expectations.
• Proven ability to manage deviations, investigations, CAPAs, and change controls.
• Experience with audits, inspections, and quality metrics is preferred.
• Strong analytical, organizational, and communication skills.

Responsibilities

• Independently support deviations, investigations, CAPAs, change controls, and QMS activities.
• Review quality records for completeness and regulatory compliance.
• Coordinate with Manufacturing, QC, Validation, Engineering to progress records.
• Assist root-cause analysis, risk assessments, and corrective actions.
• Track records against timelines and escalate delays or risks.
• Support Quality KPI data collection and trend reporting.
• Contribute to process improvements and audits readiness.

Skills

GMP knowledge

Quality systems

Deviations handling

CAPAs

Change controls

Root-cause analysis

Data tracking and trends

Education

Bachelor’s degree in Life Sciences or related field

High School diploma or equivalent

Tools

QMS software

Document control tools

Quality KPI reporting tools

Job description

PCI Pharma Services in San Diego, CA seeks a Quality Systems Specialist II to advance increasingly complex QA/QMS activities and ensure records are complete, compliant, and inspection-ready. You will support deviations, investigations, CAPAs, and change controls, coordinating with cross-functional teams to push records forward with limited supervision.

The role requires strong analytical and communication skills, with exposure to GMP and international regulatory expectations.