mRNA QC Lab Coordinator

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Laboratory Setting

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Joining the mRNA QC Lab, you will be included in a dynamic environment and you will gain and in-depth experience of a GMP Quality control lab passionate about new projects and technology transfers.

In this role, you will be responsible for overseeing the day-to-day operations of the Quality Control laboratory, ensuring compliance with cGMP requirements and company quality standards. You will coordinate laboratory activities and ensure the timely review and approval of laboratory documentation.

A key aspect of the role will be the management of QC quality systems, including the handling of laboratory events as analytical not conformities, laboratory deviations, OOS investigations, CAPAs, change controls, and laboratory documentation. You will be responsible for maintaining and updating SOPs, analytical methods, protocols, reports, and other GMP-controlled documents, ensuring data integrity and regulatory compliance.

You will support the qualification, calibration, and maintenance of laboratory instruments, oversee laboratory procedures, and ensure adherence to established quality and safety standards. In addition, you will lead and mentor QC laboratory personnel, fostering a culture of quality, continuous improvement, and operational excellence.

The role requires close collaboration with cross-functional teams to support inspections, audits, process improvements, and overall laboratory compliance.

REQUIREMENTS:
• Minimum 4 years of experience in quality control within a regulated environment (pharmaceutical/medical device preferred)
• Preferred Fields of Study: Chemistry, Biology, or related scientific field
• Demonstrated proficiency with analytical testing equipment and techniques (HPLC, GC, spectrophotometry)
• Strong understanding of cGMP requirements and quality systems
• Experience with quality documentation and data review
• Proven ability to lead and mentor others while maintaining quality standards
• Excellent attention to detail and organizational skills
• Strong verbal and written communication abilities
• Proficiency with standard office software and LIMS systems
• Ability to work in cleanroom environments and follow gowning procedures
• Physical ability to stand for extended periods, lift up to 25 lbs occasionally
• Flexibility to work various shifts as needed
• Problem-solving skills and ability to troubleshoot technical issues
• Experience writing and reviewing SOPs and technical documentation

ThermoFisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.