Quality Systems Specialist II

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

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

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.

• 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

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 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.


• Consistent delivery across multiple priorities with limited supervision.


• Demonstrated readiness to manage more complex assignments and provide increased technical guidance to others.

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.

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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

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.