Lead QA Technician, Batch Record Review (1st shift)

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

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JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

Join our team at Thermo Fisher Scientific to contribute to vital projects, such as curing cancer, safeguarding the environment, and ensuring food safety.

Location/Division Specific Information

This position is located at our Greenville, NC site. We have industry-leading sterile injectable facilities providing solutions to take crucial products from Pre-Clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointments, and injectables.

How you will make an impact

Provide direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensures the site operates in compliance with regulatory standards that ensure product quality, avoid stoppages, and reinforce customer happiness. Typical working hours are 8:00a - 5:00p, Monday through Friday.

What will you do?

Process and manage projects of moderate complexity, performing compliance assessments and making decisions regarding regulatory requirements.
Provide internal and external customer support as needed.
Lead and participate in quality initiatives and compliance improvements, product transfers, and facility expansions.
Perform document reviews and make determinations regarding adherence to current procedures and regulatory expectations.
Conduct risk assessments and take appropriate actions during quality oversight activities.
Make QA decisions and client release decisions.
Align with all job-related safety and training requirements.
Perform other duties as assigned.

How will you get here?

Associate Degree minimally required, preferably in technology, engineering, or a scientific related field.
Bachelor Degree in Computer Science, Chemistry, Biology, or other technical or physical/life science preferred.
2-3 years of related/transferable experience in operations/laboratory or STEM with the possession of an Associate's degree OR up to 2 years related/transferable experience with the possession of a Bachelor's degree.
Experience in Quality Assurance, Quality Control, or Operations/Manufacturing in a regulated industry preferred.

Knowledge, Skills, Abilities

Outstanding interpersonal skills to establish and maintain effective working relationships with employees and the public.
Highly effective verbal and written communication skills.
Outstanding attention to detail and organizational skills.
Self-starter, mature, independent, and dependable.
Demonstrated ability to mentor professional staff, evaluate and resolve complex technical problems.
Ability to command authority and remain firm in complex situations.
Ability to motivate, energize, and retain key staff.
Requires discretion and independent judgment.
Multiple digital literacy including experience with MS Office applications and general experience in computer systems associated with quality systems.

Physical Requirements:

Perform ambulatory tasks, lift, carry light to medium weights, use hands for typing, and have visual acuity.

At Thermo Fisher Scientific, each one of our 100,000+ outstanding minds has an unusual story to tell. Join us and contribute to our unusual mission—enabling our customers to make the world healthier, cleaner, and safer.