Quality Control Instrument Support Specialist II (QCIS)
Quality Control | Swiftwater, PA | First Shift
Position Summary
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.
Key Responsibilities
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
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.
Demonstrate ***'s Play to Win behaviors by prioritizing patients, acting decisively, collaborating effectively, and driving 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)
Instrument qualification and maintenance practices
Proficiency with computerized systems used in laboratory and quality environments.
Strong written, verbal, and technical 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 laboratory instrumentation in a regulated environment.
Experience with analytical instrumentation such as HPLC, GC, spectroscopy, dissolution, TOC, conductivity, particle counters, balances, microbiological laboratory systems, or other QC laboratory equipment.
Experience with computerized laboratory systems and electronic quality management systems (eQMS).
Familiarity with equipment lifecycle management, computerized system validation (CSV), analytical instrument qualification (AIQ), and risk-based compliance approaches.
Demonstrated project leadership and continuous improvement experience.
Strong customer service orientation and stakeholder management skills.
Core Competencies
Instrument Lifecycle Management
GMP Compliance and Data Integrity
Technical Troubleshooting
Quality Systems Management
Project Leadership
Continuous Improvement
Regulatory Inspection Readiness
Cross-Functional Collaboration
Technical Writing and Documentation
Laboratory Technology Implementation