Pharmaceutical Quality Control Technician II (contract)

Sanofi; Swiftwater (Monroe County); On-site; USD 28,000 - 47,000; Full time

Job summary

Sanofi is seeking a Quality Control Technician II in Swiftwater, PA, on site for a 12-month contract. You will support qualification, calibration, PM, and documentation for QC lab instrumentation within a cGMP environment.

Collaborate with QC, Engineering, Validation, QA, Manufacturing, and external vendors to uphold data integrity and regulatory readiness. Ideal candidates have 2+ years in a regulated pharma QC setting, experience with instrument qualification and GMP docs, and strong

Qualifications

• Minimum 2 years of cGMP-regulated pharma QC laboratory experience.
• Experience supporting laboratory instrumentation in a regulated environment preferred.
• Proven ability to author/revise GMP documents (SOPs, protocols, technical assessments).
• Demonstrated project leadership and improvements experience preferred.

Responsibilities

• Support qualification, calibration, preventive maintenance, troubleshooting, and retirement of QC instrumentation.
• Coordinate instrument lifecycle management to keep equipment compliant and reliable.
• Assist with vendor management and service coordination for lab equipment.
• Maintain documentation and asset management systems for instrumentation.

Skills

cGMP compliance

Data integrity

Deviations & CAPAs

AIQ/CSV knowledge

Instrument qualification

Preventive maintenance

Lab instrumentation

eQMS experience

Cross-functional collaboration

Technical communication

Troubleshooting

Project leadership

Lab systems (HPLC/GC)

Regulatory compliance

Customer service

Education

Bachelor's degree in Life Sciences or related

Tools

HPLC

GC

Spectroscopy

Dissolution

TOC

Conductivity

Particle counters

Balances

eQMS

CSV validation

Job description

Job Title: Quality Control Technician II

Location: Swiftwater, PA - on site

Type: Contract (W2)

Term: 12-months

Schedule: Monday - Friday; 9 AM - 5 PM ET

Pay Rate Max: $34 per hour

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Quality Control Technician II for a 12-month contract.

In this role, you will be responsible for supporting the full lifecycle management of analytical and laboratory instrumentation, ensuring all equipment remains qualified, compliant, and continuously available to support laboratory operations. Working within a dynamic, cGMP-regulated environment, you will collaborate closely with QC laboratories, Engineering, Validation, Quality Assurance, Manufacturing, and external service providers to uphold the highest standards of compliance, data integrity, and inspection readiness. This position plays a critical role in maintaining the reliability and performance of laboratory instrumentation while driving continuous improvement initiatives that directly impact product quality and patient safety.

Responsibilities

• Support the qualification, calibration, preventive maintenance, troubleshooting, and retirement of QC laboratory instrumentation throughout the full equipment lifecycle
• Coordinate and execute instrument lifecycle management activities 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
• Ensure all activities are performed in compliance with cGMP regulations, data integrity requirements, site procedures, and applicable regulatory expectations
• Author, review, and revise GMP documentation including qualification protocols and reports, SOPs, work instructions, User Requirements Specifications, risk assessments, and technical assessments
• Support laboratory inspection readiness and regulatory audit preparedness
• Initiate, investigate, and support resolution of deviations, investigations, 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
• 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
• 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
• Complete all required training assignments within established timelines and maintain current knowledge of data integrity principles and evolving regulatory expectations

Skills

• Working knowledge of cGMP regulations and data integrity principles
• Proficiency with quality systems including deviations, CAPAs, and change control processes
• Experience with instrument qualification and preventive maintenance practices
• Proficiency with computerized systems used in laboratory and quality environments
• Strong written, verbal, and technical communication skills
• Effective cross-functional collaboration and stakeholder management abilities
• Technical troubleshooting and problem-solving capabilities
• Project leadership and continuous improvement mindset
• Familiarity with analytical instrumentation such as HPLC, GC, spectroscopy, dissolution, TOC, conductivity, particle counters, balances, and microbiological laboratory systems
• Experience with computerized laboratory systems and electronic quality management systems (eQMS)
• Knowledge of equipment lifecycle management, computerized system validation (CSV), analytical instrument qualification (AIQ), and risk-based compliance approaches
• Strong customer service orientation and ability to manage competing priorities effectively

Experience

• Minimum 2 years of experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or quality control laboratory environment (required)
• 3 or more years of experience supporting laboratory instrumentation in a regulated environment (preferred)
• Demonstrated experience authoring and revising GMP documentation including SOPs, qualification protocols, and technical assessments
• Demonstrated project leadership and continuous improvement experience (preferred)

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline
• Ability to work on-site at the Swiftwater, PA facility
• Vaccinations as required by company policy

This is a compelling opportunity to join a globally recognized life sciences organization where your technical expertise will directly contribute to the quality and safety of vaccines and biopharmaceutical products that impact patients worldwide. You will work alongside talented cross-functional teams in a collaborative, innovation-driven environment that values continuous learning, regulatory excellence, and meaningful career development. If you are passionate about laboratory instrumentation, quality compliance, and making a tangible difference in healthcare, this role offers the ideal platform to grow your expertise and advance your career.