Now Hiring: Quality Control Instrument Support Specialist II Location: Swiftwater, PA Pay Rate: $33.12 per hour Shift: First Shift, Monday–Friday, 9:00 AM–5:00 PM EST Employment Type: Contract / Temporary Work Arrangement: On-site Position Summary We are seeking a detail-oriented Quality Control Instrument Support Specialist II to support laboratory instrumentation and quality control operations in a regulated pharmaceutical environment. This position focuses on laboratory equipment qualification, calibration, preventive maintenance, troubleshooting, documentation, and compliance with current Good Manufacturing Practices (cGMP). The specialist will collaborate with Quality Control laboratories, Quality Assurance, Engineering, Validation, Manufacturing, IT, and external service providers to maintain equipment reliability, regulatory compliance, and laboratory inspection readiness.
Key Responsibilities
Instrument Lifecycle Management
- Support qualification, calibration, preventive maintenance, troubleshooting, and retirement of QC laboratory instruments.
- Coordinate equipment lifecycle activities to ensure instruments remain qualified, reliable, and fit for intended use.
- Coordinate service activities with external vendors and equipment service providers.
- Maintain accurate instrument documentation, asset records, and equipment management systems.
- Support laboratory equipment upgrades, implementation, and performance improvements.
Quality and Regulatory Compliance
- Ensure laboratory instrumentation activities comply with cGMP requirements, data integrity principles, 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 inspection readiness and regulatory audit preparation.
- Maintain accurate, complete, and traceable documentation.
Quality Systems Support
- Initiate and support deviations, investigations, Corrective and Preventive Actions (CAPAs), and change controls.
- Collaborate with cross-functional teams to ensure quality records are completed accurately and within established timelines.
- Participate in root cause investigations and support sustainable corrective actions.
- Identify compliance risks and recommend appropriate improvements.
Technical Support and Continuous Improvement
- Provide technical support and troubleshooting for QC laboratory instrumentation.
- Support implementation of new laboratory technologies, equipment upgrades, and system enhancements.
- Participate in projects to improve laboratory efficiency, equipment reliability, and compliance.
- Identify opportunities to streamline processes and reduce operational risks.
- Maintain technical knowledge of laboratory equipment, quality systems, and industry best practices.
Collaboration and Training
- Work closely with QC, Quality Assurance, Engineering, Validation, Manufacturing, IT, and external vendors.
- Complete required training within established timelines.
- Maintain current knowledge of laboratory instrumentation, data integrity, and regulatory requirements.
- Support a collaborative, patient-focused approach to continuous improvement.
Required Qualifications
- Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 2 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or quality control laboratory environment.
- Working knowledge of cGMP regulations and data integrity principles.
- Experience or working knowledge of laboratory instrument qualification and maintenance practices.
- Familiarity with quality systems, including deviations, investigations, CAPAs, and change controls.
- Proficiency with computerized systems used in laboratory and quality environments.
- Strong written, verbal, technical communication, and documentation skills.
- Ability to collaborate effectively with cross-functional teams.
- Ability to work on-site in Swiftwater, Pennsylvania.
- Ability to meet applicable vaccination requirements under company policy.
Preferred Qualifications
- Three or more years of experience supporting laboratory instrumentation in a regulated environment.
- Experience with analytical instruments such as:
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Spectroscopy
- Dissolution testing equipment
- Total Organic Carbon (TOC) analyzers
- Conductivity meters
- Particle counters and laboratory balances
- Microbiology laboratory equipment and systems
- Experience with computerized laboratory systems and electronic Quality Management Systems (eQMS).
- Familiarity with equipment lifecycle management, Analytical Instrument Qualification (AIQ), Computerized System Validation (CSV), and risk-based compliance approaches.
- Experience leading projects and implementing continuous improvement initiatives.
- Strong stakeholder management and customer service skills.
Core Competencies
- Laboratory Instrumentation and Lifecycle Management
- GMP Compliance and Data Integrity
- Equipment Qualification and Calibration
- Technical Troubleshooting
- Quality Systems and CAPA Management
- Technical Writing and Documentation
- Regulatory Inspection Readiness
- Project Coordination and Leadership
- Continuous Improvement
- Cross-Functional Collaboration
Compensation and Schedule
- Pay Rate: $33.12 per hour
- Schedule: Monday–Friday, 9:00 AM–5:00 PM EST
- Location: Swiftwater, PA
- Work Arrangement: On-site
How to Apply Interested candidates should submit an updated resume highlighting their relevant scientific education, GMP-regulated laboratory experience, analytical instrumentation knowledge, equipment qualification experience, and quality systems expertise.
Pay Details: $33.12 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
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