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.

GROUP/DIVISION SUMMARY

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.

POSITION SUMMARY

The Lead QA Technician provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensure the site can operate without regulatory actions that impede product quality, cause product stoppages, or reduce customer satisfaction.

QUALIFICATIONS:

• High School diploma/GED required. Minimum of 3 years of proven experience; or
• Associates degree with a minimum of 2 years of experience; or
• Bachelor’s degree with a minimum of 1 year of experience.
• Degrees in Computer science, Chemistry, Biology, or other technical or physical/life science preferred.
• Equivalent combinations of education, training, and meaningful work experience in Quality Assurance may be considered
• Previous experience in the pharmaceutical industry; preferably aseptic or sterile processes strongly preferred
• Good verbal and written communication skills (legible handwriting).

• Champions quality culture by aiding personnel in understanding the application of policies and controls.
• Advances deviation events to the appropriate area and quality management
• Perform processes and projects of moderate complexity, ensuring adherence to current regulations with little dependence on others.
• Provides leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.
• Performs document reviews and makes determinations as to whether work performed meets current procedures and regulatory expectations.
• Communicates and coordinates with other departments as required to resolve issues and compliance concerns detected during review.
• Conducts risk assessments and takes appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
• Performs QA batch disposition (release) decisions.