Quality Systems Specialist

Quality Systems Specialist

The Quality Systems Specialist manages quality control (QC) analytical instrumentation and supports laboratory quality systems within a pharmaceutical environment. This role oversees the full lifecycle of QC instruments, ensures compliance with current Good Manufacturing Practices (GMPs) and data integrity requirements, and contributes to validation, investigations, and continuous improvement activities across the organization.

• Manage QC instrumentation throughout its lifecycle, including Installation, Operation and Performance Qualification (IOPQ), routine maintenance and repair, calibration and recalibration, and ongoing qualification maintenance.
• Schedule, coordinate, and liaise with external and internal service providers for instrument qualification, maintenance, and repair activities.
• Perform general troubleshooting of laboratory instruments and systems to minimize downtime and maintain data integrity.
• Generate, review, and revise protocols and reports related to instrument qualification, validation, maintenance, and repair.
• Develop, update, and maintain procedures and standard operating procedures (SOPs) related to QC analytical instrumentation and associated quality systems.
• Support the technical review of data generated from instrument qualifications, repairs, and maintenance to ensure accuracy, completeness, and compliance with regulatory requirements.
• Support laboratory investigations, including root cause analysis, and contribute to corrective and preventive action (CAPA) implementation for instrumentation and QC processes.
• Conduct troubleshooting activities or execute validation test scripts for laboratory equipment as needed.
• Populate and maintain quality metrics related to QC instrumentation, laboratory performance, and quality systems.
• Support the development and maintenance of procedural and validation lifecycle documents for QC analytical instrumentation.
• Participate in validation activities for laboratory systems and equipment, ensuring alignment with regulatory expectations and internal quality standards.
• Contribute to commercial and developmental manufacturing activities as required by quality and operational needs.
• Participate as a team member in cross-functional projects involving QC, manufacturing, quality assurance, and other stakeholders.
• Apply critical thinking and sound judgment to resolve quality issues, improve processes, and support continuous improvement initiatives.
• Communicate effectively with laboratory staff, quality teams, and cross-functional partners to articulate requirements, issues, and solutions related to QC instrumentation and quality systems.

• Working knowledge of current Good Manufacturing Practices (GMPs) and regulatory requirements for testing and validation in the pharmaceutical industry.
• Understanding and practical application of ALCOA principles for data integrity (Attributable, Legible, Contemporaneous, Original, Accurate).
• Strong knowledge of regulatory requirements surrounding data integrity and their application to laboratory and QC operations.
• Knowledge of Quality Control and Quality Management Systems within a pharmaceutical or related environment.
• Working or previous experience in general Microbiology and/or Chemistry techniques, such as gram staining, microbial identification, aseptic technique, plate streaking techniques, compendial identification tests, and complex chromatographic analyses.
• Working knowledge or hands-on experience with laboratory analytical instrumentation, including Installation, Operational, and Performance Qualification (IOPQ), validation, maintenance, and troubleshooting.
• Experience with controlled document management, including document control, change control, and procedure updates.
• Ability to apply critical thinking and good judgment in evaluating data, resolving issues, and making decisions.
• Strong organizational and problem-solving skills, with the ability to manage multiple tasks and priorities.
• Strong verbal, written, and interpersonal communication skills to collaborate effectively with cross-functional teams.
• Proficiency in Microsoft Office applications, particularly Word and Excel.
• 3 to 4+ years of relevant experience with a BS degree in a related field, or 2+ years of relevant experience with an MS degree.
• Prior experience in the pharmaceutical industry.

• Working knowledge of laboratory systems such as HPLC/UPLC, UV spectroscopy, and endotoxin kinetic chromogenic methodology (LAL) is preferred.
• Experience with laboratory computerized systems such as Empower, LIMS, and other equipment or quality management software is a plus.
• Familiarity with computerized maintenance management systems, such as IBM Maximo or similar platforms, is advantageous.
• Experience with controlled document management and change management processes is preferred.
• Highly organized with strong attention to detail and accuracy in documentation and data handling.
• Self-starter capable of…