Quality Systems Specialist I — Impact & Compliance Champion

PCI Pharma Services; San Diego (CA); On-site; USD 70,000 - 76,000; Full time

Job summary

PCI Pharma Services seeks a Quality Systems Specialist I to advance QMS records and improvement initiatives. You will coordinate with process owners and cross-functional teams to ensure records are complete, compliant, and resolved.

The role supports training, continuous improvement, and timely escalation of risks. The position operates with limited supervision, handling multiple priorities and contributing to root-cause analysis, risk assessment and corrective-action development within a

Qualifications

• Knowledge of GMP regulations and quality-system requirements.
• Experience with deviations, investigations, CAPAs and change controls.
• Experience interfacing with clients, regulators, and auditors.
• Ability to manage multiple priorities in a fast-paced setting.

Responsibilities

• Support deviations, investigations, CAPAs, change controls and QA events.
• Review quality records for completeness and compliance.
• Coordinate with Manufacturing, QC, Validation, and Engineering to progress records.
• Support root-cause analysis, risk assessments and corrective actions.
• Track records and escalate delays, risks or resource constraints.
• Assist with Quality KPI data collection and trend reporting.
• Provide training and guidance on QMS processes.

Skills

GMP knowledge

Quality systems

Document control

Regulatory knowledge

Analytical skills

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

High School diploma or equivalent

Tools

Electronic quality management systems

Quality data reporting tools

Job description

PCI Pharma Services seeks a Quality Systems Specialist I to advance QMS records and improvement initiatives. You will coordinate with process owners and cross-functional teams to ensure records are complete, compliant, and resolved.

The role supports training, continuous improvement, and timely escalation of risks. The position operates with limited supervision, handling multiple priorities and contributing to root-cause analysis, risk assessment and corrective-action development within a