Quality Assurance Officers

Life changing therapies. 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. 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

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.

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.

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.

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.

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.

The hiring rate for this position is $76,000 - 85,500 plus eligibility for an annual performance bonus. 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. 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: 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.

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. J-18808-Ljbffr PCI TRGR Penn Pharmaceutical Services Ltd