Quality Control Instrument Support Specialist II

Pay Range: $29.30hr - $34.30hr Job Overview:
The Quality Control Instrument Support Specialist II is responsible for supporting the lifecycle management of analytical and laboratory instrumentation within the Quality Control (QC) organization at the Swiftwater, PA site. This role ensures instrumentation remains qualified, compliant, and available for laboratory operations through effective execution of calibration, maintenance, qualification, and documentation activities in accordance with cGMP requirements, regulatory expectations, and 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. Instrument Lifecycle Management:
Support the qualification, calibration, preventive maintenance, troubleshooting, and retirement of QC laboratory instrumentation. Coordinate and execute activities related to instrument lifecycle management to ensure equipment remains compliant, reliable, and fit for intended use. Assist with vendor management and service coordination for laboratory equipment. Support instrumentation documentation and asset management systems. Quality and Compliance:
Ensure activities are performed in compliance with current Good Manufacturing Practices (cGMP), data integrity requirements, site procedures, and applicable regulatory expectations. Author, review, and revise GMP documentation, including qualification protocols and reports, Standard Operating Procedures (SOPs), work instructions, User Requirements Specifications (URS), risk assessments, and technical assessments. Support laboratory inspection readiness and regulatory audit preparedness. Quality Systems Support:
Initiate, investigate, and support resolution of deviations, investigations, corrective and preventive actions (CAPAs), and change controls. Collaborate with cross-functional stakeholders to ensure quality system records are completed accurately and within established timelines. Contribute to root cause investigations and implementation of sustainable corrective actions. Continuous Improvement and Projects:
Support implementation of new laboratory technologies, instrumentation upgrades, and system enhancements. Lead or participate in projects focused on improving laboratory efficiency, reliability, and compliance. Identify opportunities to streamline processes, enhance equipment performance, and reduce operational risk. Technical Support and

Collaboration:

Develop and maintain expertise in analytical instrumentation, laboratory systems, and industry best practices. Provide technical guidance and support for instrument-related issues within the QC laboratories. Partner effectively with laboratory personnel, Quality Assurance, Validation, Engineering, Information Technology, and external vendors. Training and Development:
Complete all required training assignments within established timelines. Maintain technical knowledge of laboratory instrumentation, data integrity principles, and evolving regulatory expectations. Prioritize patients, act decisively, collaborate effectively, and drive 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, or quality control laboratory environment. Working knowledge of cGMP regulations, data integrity principles, quality systems (deviations, CAPAs, change control), and instrument qualification and maintenance practices. Proficiency with computerized systems used in laboratory…