QA Auditor I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory

guidelines and/or client contractual obligations. Identifies and applies company policies and procedures to resolve routine issues. Delivers billable quality services for clients and projects. This role assures the quality of lab data and reports.

Functions and Other Job Information:

Functions

• Audits laboratory data for compliance with methods and standard operating procedures and report findings
• Audits sample result tables and analytical reports for completeness and accurate representation of the data and findings
• Serves as support to operational departments on audit or quality assurance subject matter
• Assists in the preparation of audit findings and/or other related information
  
  

Job Complexity

Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be

readily acquired.

Job Knowledge

Learns to use professional concepts.

Supervision Received

Normally receives detailed instructions on all work.

Business Relationships

Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and meaningful experience is

acceptable in lieu of Bachelor's degree

Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’).

Knowledge, Skills and Abilities:

• Familiar with applicable GxP and appropriate regional regulations
• Detailed understanding of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Able to work independently or in a team
• Strong problem solving abilities
• Strong interpersonal and time management skills
• Computer experience and ability to learn and become proficient with appropriate software
• Flexibility and adaptability
• Valid driver's license and able to qualify for and maintain a corporate credit card with sufficient credit line for business travel
  
  

Management Role:

No management responsibility

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.
  
  

Ability to work in an upright and /or stationary position for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to multi-task and perform under stress.
• Regular and consistent attendance.