Lead QA Technician (8hr days, Monday-Friday)

Work Schedule

First Shift (Days)

Environmental Conditions

Office

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.

• Location/Division Specific Information:
• The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

How You Will Make an Impact Join Thermo Fisher Scientific as a Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines. Shift is Monday-Friday, 8hr days.

A Day in the Life

Provide independent quality oversight of GMP manufacturing operations, including aseptic processing

Perform and lead batch record review to ensure accuracy and compliance with regulatory and internal requirements

Lead and support deviation investigations, root cause analysis, and CAPA development and effectiveness checks

Utilize electronic quality systems such as TrackWise and Documentum to manage documentation and workflows

Partner with Manufacturing, Validation, Engineering, and Regulatory teams to support compliant operations

Support and participate in regulatory inspections, internal audits, and customer audits

Apply knowledge of aseptic manufacturing controls, cleanroom operations, and gowning practices

Mentor and provide technical guidance to QA Technicians and peers

Identify opportunities for continuous improvement and quality system enhancements

Ensure compliance with site procedures, safety requirements, and data integrity standards

Education:

High School Diploma or equivalent required.

Preferred Fields of Study: Chemistry, Pharmacy, Biology, Biotechnology or related scientific field

Experience

Minimum of three (3) years of experience in pharmaceutical quality assurance or related GMP environment, four (4) years preferred.

Equivalent combinations of education, training, and relevant work experience may be considered

Knowledge, Skills, and Abilities

Expertise in batch record review, deviation investigations and CAPA management

Strong understanding of aseptic manufacturing processes and controls

Professional communication skills both written and spoken

Ability to manage multiple priorities in a dynamic environment

Strong attention to detail and analytical problem-solving skills

Effective interpersonal and communication abilities

Project management and organizational capabilities

Experience supporting regulatory inspections and customer audits

Demonstrated ability to work effectively with cross-functional teams

Proficiency with Microsoft Office applications

Ability to work various shifts as required

Demonstrated ability to guide and develop team members

Ability to understand and interpret technical procedures and specifications