Quality Management System Specialist

Quality Management System Specialist Sterling Pharmaceutical Services, LLC East Carondelet, IL Job Details Full-time $65,000 - $85,000 a year 8 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Teamwork Microsoft Excel Microsoft Outlook Microsoft Office Bachelor's degree Root cause analysis Technical Proficiency Full Job Description Job Summary We are seeking a dynamic and detail-oriented Quality Management System (QMS) Specialist is responsible for the administration, governance, and continuous improvement of the site Quality Management System (QMS), with a primary focus on deviation, investigation, and CAPA processes. This role ensures that quality events are thoroughly investigated, root causes are scientifically justified, and corrective/preventive actions are effective, sustainable, and compliant with cGMP requirements. The role serves as a key quality partner to Manufacturing, QC, and Technical Operations, ensuring that quality systems enable compliant and efficient operations in a paper-based environment.

Duties :

QMS Ownership (Paper-Based System) Own and maintain the site QMS, including deviations, CAPAs, change control, complaints, and OOS Ensure systems are compliant with cGMP expectations and inspection-ready at all times Maintain controlled workflows, logs, and archival processes for paper-based records Drive simplification and standardization of QMS processes to improve usability and compliance • Investigations Oversight Lead and oversee deviation and investigation activities for quality events, drive completion and effectiveness Ensure investigations are scientifically sound, root-cause focused (not symptom based), timely and well-documented Provide guidance on investigation tools (e.g., 5-Why, Fishbone, fault tree analysis) and train staff regularly to improve skills Review and approve investigation reports and associated CAPAs Escalate critical quality issues and trends to QA leadership while offering support and solutions CAPA Effectiveness & Compliance Ensure CAPAs are appropriate, risk-based, and effective Track CAPA implementation and verify effectiveness checks Prevent recurrence through systemic improvements rather than localized fixes Trending & Continuous Improvement Trend deviations, CAPAs, and quality events to identify recurring issues and systemic risks, implement KPIs regarding the system Present metrics and insights to site leadership and for Quality Management Reviews Drive continuous improvement initiatives based on data Inspection Readiness Support internal and external audits and regulatory inspections Act as SME for QMS and investigations during inspections Ensure documentation is complete, accurate, and readily retrievable Cross-Functional Collaboration Partner with Manufacturing, QC, and Engineering to ensure quality systems support operations Provide training and coaching on investigation quality and QMS processes Drive accountability across functions for timely closure of quality records Complete Annual Product Review on all commercial products and coordinate the completion of annual retains review Approved Suppliers List - manage the supplier approval documentation process including supplier survey process, coordination of on-site or virtual audits, updates of the Active Approved Supplier List, maintain physical and electronic files of supplier approvals, notify when re-audits are due so they can be scheduled Qualifications Bachelor's degree preferred 5+ years' experience in pharmaceutical or related industry preferred Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required This role requires a detail-oriented individual with strong investigative skills and a proven ability to identify root causes of quality issues in a regulated pharmaceutical manufacturing environment The ideal candidate is a self-starter who thrives in a fast-paced environment, with a demonstrated ability to drive investigations to timely closure and effectively communicate findings to cross-functional teams.

Pay:

$65,000.00 - $85,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person