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Thermo Fisher Scientific Laboratory Instrument Qualification Specialist in Florence, South Carolina

Job Title: Laboratory Instrument Qualification Specialist

Requisition ID: 153248BR

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.

Summary:

The Laboratory Instrument Qualification Specialist coordinates and manages qualification of laboratory instrumentation, ensuring compliance with GMP standards.

Key Responsibilities:

  • Coordinate instrument qualification activities include IQ/OQ/PQ, etc. [Instrumentation including, but not limited to, HPLC, GC, pipettors, water systems, hydrogen generators, KF titrators, analytical balances, etc.]

  • Manage qualificaiton schedules to ensure instrumets remain in compliance with GMP standards and site SOPs.

  • Work closely with data integrity team, IT team, and quality team to achieve consensus on qualification strategies and execution.

  • Draft Change Record documents in Trackwise system.

  • Draft protocol and report documents in Documentum EDMS.

  • 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 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Qualifications:

  • Bachelor's degree required (science field preferred)

  • 1-2 years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)

  • 1-2 years of experience working with analytical instrumentation, such as HPLC, GC, CE, ICP and dissolution apparatus preferred

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

  • New Graduates are considered.

Competencies:

Good written communication skills. Good knowledge and understanding of analytical instrumental technologies. Good knowledge of quality and regulatory requirements in the pharmaceutical industry. Good problem solving skills and logical approach to solving scientific problems. Good interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write simple protocols, reports, and change records. Ability to respond to common inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations.

Physical Requirements:

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 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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.

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.

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