Job Title: Lead QA Technician
Requisition ID: 131139BR

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location: Greenville, NC

How will you make an impact?
Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensures the site can operate without regulatory actions that impede product quality, cause product stoppages, or reduce customer satisfaction. This position will start off as an 8 hour Day shift position for training, but will ultimately transition into an 8-hour 2nd shift position with the hours of 4:00p-12:30a; Monday-Friday. Flexibility is needed for off shift hours.

What will you do?
1. Complies with all job-related safety and other training requirements. Employee’s responsibility to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
2. Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements; ensures adherence to current regulations with little dependence on others.
3. Provides leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.
4. Performs document reviews and make 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.
5. Take 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.
6. Performs QA batch disposition (release) decisions.
7. Complies with all job-related safety and other training requirements.
8. Performs other duties as assigned.

How will you get there?
Education:
Bachelor’s degree in related field (Computer science, Chemistry, Biology, or other technical or physical/life science) is required.

Experience:
Minimum three years of relevant experience is preferred.

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

Knowledge, Skills, Abilities:
Multiple computer skills including working experience with MS Office applications such as Word and Excel and general experience in computer systems associated with quality assurance functions such as lot review, SOP
review and approval, lab results reviews (LIMS), disposition of product and validation document reviews. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and
the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability
to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.