Job Description

Job Title: Sr QA Technician
Requisition ID: 148236BR

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.

Location/Division Specific Information:
Greenville, NC

How will you make an impact?
Complies with all job-related safety and other training requirements. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Processes and projects of low to moderate complexity, perform compliance assessments, makes decisions regarding regulatory requirements; ensures adherence to current regulations with little dependence on others. Typical hours for this role is an 8-hour shift from 7:00a-4:00p, Monday-Friday.

What will you do?
* 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 made 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 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.
* Provides In-Line batch record reviews.
* Complies with all job-related safety and other training requirements.
* Performs other duties as assigned.

How will you get here?
Education:
Associate's degree in Science or other technical or physical/life science is preferred.
High school diploma or equivalent is minimally required.

Experience:
3-4 years of experience in direct interaction with operations/laboratory or related STEM experience required; experience in Quality Assurance, Quality control or Operations/Manufacturing in a regulated industry and direct interaction with operations/laboratory is preferred.

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

Knowledge, Kills, 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. 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. 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. Requires discretion and independent judgment. 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.

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.