Quality Systems Specialist II

pciservices; San Diego (CA); On-site; USD 90,000 - 115,000; Full time

Job summary

PCI Services in San Diego seeks a Quality Systems Specialist II to advance GxP records, CAPAs, deviations, change controls, and QA initiatives. You will collaborate with process owners and cross-functional teams to ensure records are complete, compliant, and inspection-ready.

The role requires strong analytical skills and experience in regulated manufacturing. The position emphasizes independent work on routine assignments, timely escalation of risks, and ongoing improvements to procedures and

Qualifications

• Bachelor's degree in Life Sciences or related field; equivalent experience will be considered.
• 3-5+ years in Quality Assurance, Quality Systems, or regulated biopharma operations.
• Knowledge of GMP, FDA/EU expectations, and document control processes.

Responsibilities

• Independently support deviations, investigations, CAPAs, change controls and quality events.
• Review quality records for completeness, accuracy, and evidence.
• Coordinate with Manufacturing, QC, Validation and Engineering to progress records.
• Support root-cause analysis, risk assessments, and corrective actions.
• Track records against timelines and escalate delays or risks.
• Support Quality KPI data collection and routine trend reporting.
• Assist training and continuous improvement initiatives.
• Maintain inspection-ready documentation and support audits.

Skills

GMP knowledge

Quality systems

Problem solving

Stakeholder management

Documentation control

Audit readiness

Education

Bachelor's degree in Life Sciences or related field

Experience in QA/Quality Systems

Tools

Electronic QMS

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary

The Quality Systems Specialist II performs increasingly complex Quality Systems activities and supports the timely progression of QMS records and improvement initiatives. This role works closely with process owners and cross-functional stakeholders to ensure records are complete, compliant, and effectively resolved.

The position is expected to support assigned priorities with limited supervision, identify issues requiring escalation, and contribute to team training and process improvement.

Hours: 1st Shift

Essential Duties and Responsibilities

• Independently support assigned deviations, investigations, CAPAs, change controls, quality events, document revisions, and related QMS activities.
• Review quality records for completeness, accuracy, procedural compliance, and appropriate supporting evidence.
• Coordinate with Manufacturing, Quality Control, Validation, Engineering, and other functions to obtain information and progress records.
• Support root-cause analysis, risk assessments, corrective-action development, and effectiveness verification.
• Track assigned records against established timelines and elevate delays, risks, or resource constraints.
• Support Quality KPI data collection, verification, reconciliation, and routine trend reporting.
• Identify recurring issues or process inefficiencies and recommend practical improvements.
• Support audit and inspection readiness, including document retrieval, record review, and response preparation.Serve as a knowledgeable resource for assigned QMS processes.
• Provide training or day-to-day guidance to Quality Systems Specialist I personnel and process owners.
• Participate in continuous improvement projects and implementation of revised procedures or systems.
• Maintain accurate and inspection-ready documentation.

Level Expectations

• Operates independently on routine and increasingly complex assignments.
• Requires periodic guidance for high-risk, novel, or highly complex issues.
• Manages multiple priorities and communicates risks before timelines are affected.
• Applies established procedures and regulatory principles with sound judgment.
• Contributes to problem-solving, training, and process improvement.
• May lead defined workstreams or small improvement projects.

Qualifications

• High School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred; equivalent combination of education and/or relevant work experience will be considered.
• 3-5 or more years of experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry.
• Demonstrated knowledge of GMP regulations and quality-system requirements, including applicable FDA, EU, and international regulatory expectations.
• Experience managing or supporting deviations, investigations, CAPAs, change controls, document control, training, audits, inspections, and quality metrics.
• Experience supporting sterile, biologic, pharmaceutical, or contract manufacturing operations preferred.Demonstrated experience interacting with clients, regulatory agencies, and internal or external auditors.
• Strong analytical, organizational, problem-solving, and decision-making skills.
• Ability to support multiple priorities in a fast-paced, complex manufacturing environment.
• Strong written, verbal, presentation, and stakeholder-management skills.
• Proficiency with electronic quality management systems and quality-data reporting tools preferred.

Success Measures

• Independent and timely support of assigned deviations, investigations, CAPAs, change controls, and quality events.
• Accurate, complete, and inspection-ready quality records with minimal rework.
• Effective coordination with process owners and cross-functional partners to maintain record progression and meet established timelines.
• Appropriate application of root-cause analysis, risk assessment, corrective-action principles.
• Timely escalation of compliance risks, delays, or resource constraints before deliverables are affected.
• Accurate Quality KPI data collection, verification and routine trend reporting.
• Meaningful contributions to process improvements that increase efficiency