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PCI
San Diego, CA, USA; USA_CA_San Diego_Roselle
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
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.
The Quality Systems Specialist I performs moderately 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.
To perform this job successfully, an iNdividual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.
Support assigned deviations, investigations, CAPAs, change controls, quality events, document revisions, and related QMS activities under supervision of management and peers.
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 escalate 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 assignments.
Requires periodic guidance for high-risk, novel, or highly complex issues.
Supports 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.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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