Quality Systems Specialist II — GMP Compliance & CAPA Excellence

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego, Northern (CA, KY); Hybrid; USD 76,000 - 86,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

PCI Pharma Services is seeking a Quality Systems Specialist II to advance QMS records and drive improvement initiatives across cross-functional teams. You will support deviations, CAPAs, change controls, and audits while ensuring records are complete and compliant.

The role partners with Manufacturing, Quality Control, Validation, and Engineering to resolve issues, track timelines, and contribute to continuous process improvements in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in Life Sciences or related field; equivalent combination of education and/or relevant work experience will be considered.
• 3-5+ years in Quality Assurance or Quality Systems in pharmaceutical manufacturing, biotechnology, or related regulated industry.
• Demonstrated knowledge of GMP regulations and quality-system requirements, including FDA, EU, and international 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.
• Strong analytical, organizational, problem-solving, and decision-making skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong written, verbal, presentation, and stakeholder-management skills.
• Proficiency with electronic quality management systems and quality-data reporting tools preferred.

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.

Skills

Analytical skills

Organizational skills

Problem-solving

Decision-making

Education

Bachelor's degree in Life Sciences

Tools

QMS software

Quality data reporting tools

Job description

PCI Pharma Services is seeking a Quality Systems Specialist II to advance QMS records and drive improvement initiatives across cross-functional teams. You will support deviations, CAPAs, change controls, and audits while ensuring records are complete and compliant.

The role partners with Manufacturing, Quality Control, Validation, and Engineering to resolve issues, track timelines, and contribute to continuous process improvements in a fast-paced biopharma environment.