QC Instrument Lifecycle & Compliance Specialist II

HireLifeScience; Swiftwater (Monroe County); On-site; USD 75,000 - 110,000; Full time

Job summary

HireLifeScience is seeking a Quality Control Instrument Support Specialist II in Swiftwater, PA. The role ensures calibration, maintenance and lifecycle management of QC analytical instrumentation to keep labs compliant and inspection-ready.

The position requires collaboration with QC labs, Engineering, Validation, QA, Manufacturing and external vendors, with focus on data integrity, cGMP adherence and continuous improvement initiatives.

Qualifications

• Bachelor's degree required in a life sciences or related field.
• 2+ years in a cGMP-regulated lab environment.

Responsibilities

• Support qualification, calibration, preventive maintenance and retirement of QC instrumentation.
• Coordinate and execute instrument lifecycle management to ensure compliance and reliability.
• Assist with vendor management and service coordination for lab equipment.
• Develop and maintain instrument documentation and asset management records.
• Ensure activities comply with cGMP, data integrity and regulatory expectations.
• Prepare and revise GMP documentation including SOPs, URS, risk assessments and reports.
• Support inspection readiness and regulatory audits.
• Lead or participate in projects to improve lab efficiency and compliance.

Skills

Instrument lifecycle management

GMP compliance

Data integrity

Cross-functional collaboration

Troubleshooting

Technical writing

Communication skills

Education

Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related field

Tools

LIMS

eQMS

CSV concepts

QA/documentation tools

Job description

HireLifeScience is seeking a Quality Control Instrument Support Specialist II in Swiftwater, PA. The role ensures calibration, maintenance and lifecycle management of QC analytical instrumentation to keep labs compliant and inspection-ready.

The position requires collaboration with QC labs, Engineering, Validation, QA, Manufacturing and external vendors, with focus on data integrity, cGMP adherence and continuous improvement initiatives.