Quality Systems Specialist

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Job Title: Quality Systems Specialist

Location: Assembly Drive, Rockford, IL

1st shift

Summary of Objective:

The Quality Systems Specialist is responsible for supporting and maintaining core elements of the Quality Management Systems (QMS) for the Linden Road facilities, Advanced Drug Delivery teams. This includes change control, CAPA, deviations, investigations, document control, internal audits, and quality system metrics. This role oversees the day-to-day coordination, execution, and monitoring of QMS activities to ensure compliance with regulatory requirements and internal quality standards. The Quality Systems Specialist serves as the primary point of contact for QMS-related requests and cross-functional collaboration, and prioritizes daily work, and provides governance tracking, reporting, trending, and follow-up across key quality systems. This role conducts routine health checks, supports audits, investigations, and drives continuous improvement to ensure the QMS remains effective, compliant, and inspection-ready.

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.

Maintain and support the site Quality Management System (QMS) in alignment with regulatory and internal requirements Serve as the primary point of contact for QMS-related questions, requests, and cross-functional support. Coordinate daily QMS activities including Change Controls, CAPAs, Deviations, investigations, and document control tasks and periodic document reviews. Manage the eDMS (Master Control), ensuring workflow and documents are created, revised, approved, and archived correctly. Initiate, review, and track Change Controls to ensure proper scoping, impact assessments, risk evaluations, and on-time closure. Support deviation and nonconformance investigations, ensuring appropriate root-cause analysis and documentation is adequate for closure. Maintain and track CAPA records, ensuring actions are properly defined, executed, verified, and closed. Conduct CAPA effectiveness checks and follow-up activities to ensure long-term sustainability of corrective actions. Prepare and maintain QMS metrics, QMS Governance Boards, dashboards, weekly, monthly and quarterly reports. Support Management Review data preparation, including trending, historical analysis, risk indicators, and performance summaries. Conduct pre-audit readiness reviews and health checks to proactively identify compliance gaps. Track and follow up with owners on overdue, at-risk, or upcoming QMS deliverables. Support the internal audit program, including scheduling, audit preparation, execution, documentation, and follow-up. Support external audits (customer, regulatory, internal, etc.). Maintain readiness for audits and inspections by ensuring all QMS and documents meet ALCOA+ and data integrity requirements. Maintain QMS logs, trackers, and master lists, ensuring data accuracy and compliance with data integrity requirements. Support risk management activities, including risk assessments, risk registers, etc. Identify trends, patterns, and recurring issues that require CAPAs or process improvements. Ensure all QMS activities follow established procedures, industry standards, and regulatory expectations. Assist with drafting, revising, and formatting SOPs, WIs, forms, and templates related to QMS functions. Facilitate cross-functional communication and support for all employees. This includes providing training support to ensure personnel are trained in new or revised QMS processes and documentation. Participate in quality and continuous improvement projects to enhance QMS efficiency and effectiveness. Provide routine communication updates to leadership on QMS performance, risks, and improvement opportunities.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 1-3 years related experience and/or training.

• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred

• Ability to demonstrate attention to detail.
• Ability to work independently and/or part of a team.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.

#LI-KH1

For Illinois residents: the hiring rate for this position is $62,960.00 to $70,830.00 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), flexible spending account, and 401(k).

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.