Quality Systems Specialist II

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

Benefits offered by this job

Paid time off

Health insurance coverage (dental &amp

Vision)

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services in San Diego, CA seeks a Quality Systems Specialist II to advance complex Quality Systems activities and drive timely progression of QMS records.

The role supports root-cause analysis, risk assessment, CAPAs, and change controls while maintaining inspection-ready documentation and coordinating with process owners and cross-functional teams.

Qualifications

• Experience in Quality Assurance within regulated pharmaceutical environments.
• Familiarity with GMP regulations and quality-system requirements (FDA/EU).
• Experience managing deviations, investigations, CAPAs, change controls, audits, and document control.

Responsibilities

• Independently support deviations, investigations, CAPAs, change controls, quality events, document revisions, and related QMS activities.
• Review quality records for completeness, accuracy, and procedural compliance with supporting evidence.
• Coordinate with Manufacturing, QA, Validation, Engineering and others to progress records.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Data analysis

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Life Sciences or related field

Tools

Electronic QMS

Quality data reporting tools

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 escape 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, and 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, compliance, or record quality.
• Effective support of audit and inspection-readiness activities.

The hiring rate for this position is $76,000 - 85,500 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

• paid time off
• health insurance coverage (including dental and vision)
• a flexible spending account
• a 401(k) plan

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

#LI-AC1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future