Quality Control Instrument Support Specialist II

A primary focus of this role is supporting the temperature mapping and qualification of Controlled Temperature Units (CTUs), including refrigerators, freezers, cold rooms, incubators, stability chambers, and other temperature-controlled equipment. The ideal candidate will have hands-on CTU qualification and temperature mapping experience, preferably using Ellab data loggers or comparable temperature mapping systems. Candidates with strong experience in analytical laboratory instrument qualification (AIQ) will also be considered.

The role ensures equipment and instrumentation remain qualified, compliant, and available for laboratory operations through effective execution of temperature mapping, calibration, maintenance, qualification, troubleshooting, and documentation activities in accordance with cGMP requirements, data integrity principles, regulatory expectations, and site quality standards.

The position works collaboratively with QC laboratories, Engineering, Validation, Quality Assurance, Manufacturing, and external service providers to maintain inspection readiness and support continuous improvement initiatives.

Key Responsibilities:

CTU Mapping and Qualification

• Execute and support temperature mapping and qualification of Controlled Temperature Units (CTUs), including refrigerators, freezers, cold rooms, incubators, stability chambers, and other temperature-controlled equipment.
• Perform CTU temperature mapping studies using Ellab data loggers or comparable systems, including logger preparation, configuration, placement, deployment, data collection, retrieval, and post-study data review.
• Support the development, review, and execution of CTU mapping and qualification protocols, including initial qualification, periodic requalification, and qualification following equipment changes, relocation, significant maintenance, or other applicable events.
• Evaluate mapping data against approved specifications and acceptance criteria and support the identification and investigation of temperature excursions, hot/cold spots, sensor issues, data anomalies, and other study discrepancies.
• Support IQ/OQ/PQ activities associated with CTUs and other temperature-controlled equipment.
• Troubleshoot Ellab data loggers and related temperature mapping equipment and coordinate technical support with vendors when required.
• Maintain appropriate temperature mapping records, raw data, calibration documentation, qualification packages, reports, and traceability documentation.

Analytical Instrument Qualification and Lifecycle Management

• Support the qualification, calibration, preventive maintenance, troubleshooting, and retirement of QC analytical and laboratory instrumentation.
• Execute or support analytical instrument qualification (AIQ) activities, including IQ/OQ/PQ, functional testing, calibration verification, protocol execution, data review, and final qualification documentation.
• Coordinate instrument lifecycle activities to ensure laboratory equipment remains compliant, reliable, and fit for intended use.
• Support qualification and lifecycle activities for instrumentation such as HPLC, ., spectroscopy equipment, dissolution systems, TOC analyzers, conductivity meters, particle counters, balances, and microbiological laboratory equipment, as applicable.
• Assist with vendor management and service coordination for CTUs, analytical instruments, and other laboratory equipment.
• Support instrumentation documentation and asset management systems.

Quality and Compliance

• Ensure CTU mapping, instrument qualification, calibration, and maintenance activities are performed in compliance with cGMP, data integrity requirements, site procedures, approved protocols, and applicable regulatory expectations.
• Author, review, and revise GMP documentation, including:
  • Qualification and mapping protocols and reports
  • Standard Operating Procedures (SOPs)
  • Work instructions
  • User Requirements Specifications (URS)
  • Risk assessments
  • Technical assessments
• Ensure electronic and paper data generated during mapping and instrument qualification activities meet applicable data integrity and traceability requirements.
• Support laboratory inspection readiness and regulatory audit preparedness.

Quality Systems Support

• Initiate, investigate, and support the resolution of deviations, investigations, CAPAs, and change controls associated with CTUs, laboratory instrumentation, qualification activities, and equipment performance.
• Collaborate with cross-functional stakeholders to ensure quality system records are completed accurately and within established timelines.
• Contribute to root cause investigations involving equipment failures, mapping discrepancies, temperature excursions, qualification failures, and other instrument-related issues.
• Support implementation and documentation of sustainable corrective and preventive actions.

Continuous Improvement and Projects

• Support implementation of new CTUs, laboratory technologies, analytical instrumentation, equipment upgrades, and system enhancements.
• Lead or participate in projects focused on improving laboratory efficiency, equipment reliability, qualification processes, and compliance.
• Identify opportunities to streamline mapping and qualification processes, enhance equipment performance, and reduce operational and compliance risks.

Technical Support and Collaboration

• Develop and maintain expertise in CTU qualification, temperature mapping, analytical instrumentation, equipment qualification, and laboratory systems.
• Provide technical guidance and troubleshooting support for CTU, temperature mapping, and analytical instrumentation issues.
• Partner effectively with QC laboratory personnel, Quality Assurance, Validation, Engineering, Manufacturing, Information Technology, and external equipment/service vendors.

Training and Development

• Complete all required training assignments within established timelines.
• Maintain technical knowledge of CTU mapping, analytical instrument qualification, laboratory instrumentation, data integrity principles, cGMP requirements, and evolving regulatory expectations.
• Demonstrate strong collaboration, accountability, sound judgment, and commitment to continuous improvement.

Required Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 2 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, validation, engineering, or quality control laboratory environment.
• Hands-on experience in equipment or instrument qualification, including execution or support of IQ/OQ/PQ activities.
• Experience with CTU temperature mapping and qualification and/or analytical laboratory instrument qualification.
• Working knowledge of:
  • cGMP requirements
  • Data integrity principles
  • Equipment and instrument qualification
  • IQ/OQ/PQ methodology
  • Calibration and preventive maintenance
  • Deviations, CAPAs, investigations, and change control
• Experience executing approved protocols and reviewing qualification data against established acceptance criteria.
• Proficiency with computerized systems used in laboratory, validation, and quality environments.
• Strong written, verbal, technical documentation, and communication skills.
• Ability to effectively collaborate within cross-functional teams.
• Ability to work on-site at the Swiftwater, PA facility.
• Vaccinations as required by company policy.

Preferred Qualifications

• 3+ years of experience supporting CTU qualification, laboratory instrumentation, validation, or equipment lifecycle activities within a regulated environment.
• Hands-on CTU mapping and qualification experience, including refrigerators, freezers, cold rooms, incubators, stability chambers, or comparable temperature-controlled equipment.
• Experience performing temperature mapping studies using Ellab data loggers or comparable temperature mapping/data acquisition systems.
• Experience with logger configuration, placement, deployment, data retrieval, analysis, and troubleshooting.
• Experience authoring and executing CTU mapping and qualification protocols and reports.
• Experience with analytical laboratory instrument qualification (AIQ), including IQ/OQ/PQ execution and documentation.
• Experience supporting analytical instrumentation such as HPLC, ., spectroscopy, dissolution, TOC, conductivity, particle counters, balances, microbiological laboratory systems, or other QC instrumentation.
• Experience with computerized laboratory systems and electronic quality management systems (eQMS).
• Familiarity with equipment lifecycle management, computerized system validation (CSV), analytical instrument qualification, and risk-based compliance approaches.
• Experience investigating qualification failures, temperature excursions, equipment discrepancies, or mapping anomalies.
• Demonstrated project leadership and continuous improvement experience.
• Strong customer service orientation and stakeholder management skills.

Core Competencies

• CTU Temperature Mapping and Qualification
• Ellab Data Logger Operation and Troubleshooting
• Analytical Instrument Qualification (AIQ)
• IQ/OQ/PQ Execution
• Instrument and Equipment Lifecycle Management
• Calibration and Preventive Maintenance
• GMP Compliance and Data Integrity
• Qualification Protocol Execution and Documentation
• Technical Troubleshooting
• Deviations, CAPAs, Investigations, and Change Control
• Regulatory Inspection Readiness
• Cross-Functional Collaboration
• Technical Writing and Documentation
• Continuous Improvement
• Laboratory Technology Implementation