Sr. QA Technician: Records Specialist (8hr days, Monday-Friday)

Work Schedule First Shift (Days) Environmental Conditions Office Job Description Job Description Location/Division Specific Information As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization. How Will You Make an Impact The Sr. Quality Technician, Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensures the site operates in compliance with regulatory standards that ensures product quality, avoids stoppages and reinforces customer satisfaction. Day shift hours are Monday-Friday, 8am-5pm. A Day in the Life Follow all job-related safety and other training requirements. 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 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. Advances deviation events to the appropriate area and quality management. Performs 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. Advances deviation events to the appropriate area and quality management Education High School Diploma or equivalent required Associates degree or higher in Science or Technology is preferred

Experience Required:

Minimum of 2 years of work experience in QA or QC or related field

Required:

Experience in a cGMP environment Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, Abilities Outstanding attention to detail and organizational skills. Self-starter, mature, independent and reliable Ability to work in a fast-paced environment under pressure and able to multi-task. Effective time management and prioritization skills. Requires discretion and independent judgment. Highly effective verbal and written communication skills. Ability to work on a team and help lead that team to be successful and productive. Physical Requirements/Work Environment Use Personal Protective Equipment (PPE) and understand chemical hygiene. Infrequently lift and manipulate up to 50 pounds max unassisted. Stand and move about including reaching, bending, stooping, grasping. Use hand tools and equipment including forceful gripping, grasping, pushing and pulling. Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.