Qualification Specialist

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities:

• Preparation and completion of data integrity risk assessments for computerized system in the laboratory. This includes, but is not limited to, interacting with instrument vendor to understand data flow, application software features, data file generated and Part 11 compliance features on the application software.
• Working closely with instrument owner to setup the system and complete data integrity risk assessment in assigned timelines
• Working on instrument qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning and documentation archival
• Review and approve vendor-executed calibration, maintenance, repair, and performance verification work.
• Monitor schedules to ensure timely completion of calibration, performance verification testing, and maintenance services.
• Collaborate with the quality unit to ensure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards
• Management of user accounts, password reset etc., as requested by users
• Verification of data backup and restore activities
• Participation in preparation of standard operating procedures

Education and Experience:

• Bachelor's degree in Chemistry, Biology, Computer Science or similar and relevant formal academic / vocational qualification
• AND previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Experience and understanding of 21 CFR Part 11 compliance for computer system (hardware, application software and operating system)
• Understanding of Data Integrity concepts in GxP work environment
• Experience with instrument/equipment qualification, deviation and change control process.
• Experience reviewing calibration, maintenance, repair, and performance verification work.
• Ability to create documents using existing document templates
• Possess firm understanding of data file types generated by laboratory instruments including database structure

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!